Neoplasm, Gastrointestinal
Conditions
Keywords
Adenocarcinoma Metastatic, Adenocarcinoma of the Stomach, Adenocarcinoma of the Gastroesophageal Junction, HER2 Overexpression, Adenocarcinoma, Locally Advanced, DESTINY - Gastric 01
Brief summary
The primary purpose of this trial is to compare the efficacy and safety of DS-8201a and physician's choice treatment in HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens including fluoropyrimidine agent, platinum agent, and trastuzumab.
Interventions
DRUGDS-8201a
DS-8201a is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration.
Either: Irinotecan monotherapy (Starting dosage and usage is 150 mg/m2 biweekly, with dose reduction permitted) Paclitaxel monotherapy (Starting dosage and usage is 80 mg/m2 weekly, with dose reduction permitted)
Sponsors
AstraZeneca
Daiichi Sankyo Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two randomized investigative arms will run in parallel (DS-8201a and Physician's Choice), with participants who have disease progression after two previous regimens. Two non-randomized exploratory arms will run with HER2 treatment-naive participants.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Has a pathologically documented locally advanced or metastatic adenocarcinoma of gastric or gastroesophageal junction 2. Progression on and after at least 2 prior regimens 3. Has an adequate tumor sample 4. Has measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
Exclusion criteria
1. Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia 2. Has a QTc prolongation to \> 450 millisecond (ms) in males and \> 470 ms in females 3. Has a medical history of clinically significant lung disease 4. Is suspected to have certain other protocol-defined diseases based on imaging at screening period 5. Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise: 1. safety or well-being of the participant or offspring 2. safety of study staff 3. analysis of results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Baseline to date of first documented objective response (CR or PR), up to 36 months postdose | The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by independent central imaging review (ICR) based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Unconfirmed ORR (not confirmed by ICR) and confirmed ORR (confirmed by ICR) are reported. |
| Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Baseline to date of first documented objective response, up to 36 months postdose | The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by independent central imaging review (ICR) based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Unconfirmed BOR (not confirmed by ICR) and confirmed BOR (confirmed by ICR) are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | From the date of first objective response (CR or PR) to the date of first documentation of PD or death (whichever occurs first), up to 36 months postdose | Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR was measured for responding subjects (PR or CR) only. |
| Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Baseline to date of first documented objective response (CR, PR, and SD), up to 36 months postdose | Disease control rate (DCR) was defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate. As per RECIST v1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. |
| Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | From randomization to first documented objective response, up to 36 months postdose | The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Independent Central Review (ICR) based on RECIST version 1.1. The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by Investigator based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions). Confirmed ORR and BOR (confirmed by ICR) are reported. |
| Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | From date of randomization to first documentation of PD, death due to any cause, or treatment discontinuation (whichever comes first), up to 36 months postdose | Time to treatment failure (TTF) was defined as the time from the date of randomization (the date of the registration for Exploratory Cohorts) to the earliest date of the first objective documentation of progressive disease (PD), death due to any cause, or treatment discontinuation. |
| Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | From randomization to first documented objective response, up to 36 months postdose | The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Investigator based on RECIST version 1.1. The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by Investigator based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions). Unconfirmed ORR and BOR (not confirmed by Investigator) and confirmed ORR and BOR (confirmed by Investigator) are reported. |
| Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days) | Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The maximum serum concentration (Cmax) and the trough serum concentration (Ctrough) of DS-8201a were assessed. These serum PK parameters for DS-8201a and total anti-HER2 antibody were estimated in each participant using standard noncompartmental methods. |
| Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | From the date of randomization to the date of death (due to any cause), up to 36 months postdose | Duration of survival follow-up (months) was defined as the date of last contact - date of randomization/ registration + 1.Overall Survival (OS) was defined as the time from the date of randomization (the date of the registration for the Exploratory Cohorts) to the date of death due to any cause. |
| Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days) | Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Area under the concentration versus time curve (AUC) from Time 0 to the Last Quantifiable Concentration (AUClast) and Area Under the Concentration versus-Time Curve up to 21 days (AUC21d) are reported. These serum PK parameters for DS-8201a and total anti-HER2 antibody were estimated in each participant using standard noncompartmental methods. |
| Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of MAAA-1181 Following Treatment With DS-8201a | Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days) | Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Area under the concentration versus time curve (AUC) from Time 0 to the Last Quantifiable Concentration (AUClast) and Area Under the Concentration versus-Time Curve up to 21 days (AUC21d) are reported. These serum PK parameters for MAAA-1181a were estimated in each participant using standard noncompartmental methods. |
| Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days) | Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The time to maximum serum concentration (Tmax) of DS-8201a was assessed. This serum PK parameter for DS-8201a, total anti-HER2 antibody, and MAAA-1181a were estimated in each participant using standard noncompartmental methods. |
| Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days) | Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Terminal elimination half-life (t1/2) of DS-8201a was assessed. This serum PK parameter for DS-8201a, total anti-HER2 antibody, and MAAA-1181a were estimated in each participant using standard noncompartmental methods. |
| Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Baseline up to 47 days after last dose, up to 36 months postdose | A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs. |
| Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Baseline up to 47 days after last dose, up to 36 months postdose | A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. |
| Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a | Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days) | Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The maximum serum concentration (Cmax) and the trough serum concentration (Ctrough) of DS-8201a were assessed. These serum PK parameters for MAAA-1181a were estimated in each participant using standard noncompartmental methods. |
| Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | From the date of randomization to the first documented disease progression or date of death (whichever occurs first), up to 36 months postdose | Progression-free survival (PFS) was defined as the time from the date of randomization (the date of the registration for the Exploratory Cohorts) to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions. |
Countries
Japan, South Korea
Participant flow
Recruitment details
In the Primary Cohort, a total of 188 participants who met all inclusion criteria and no exclusion criteria were enrolled and randomized to treatment. In the Exploratory Cohorts, a total of 45 non-randomized participants were enrolled and 44 patients received treatment. Study participants for all cohorts were enrolled at clinic sites in South Korea and Japan. Participants took part of the study from November 2, 2017 to Data Cut-Off (DCO) date of December 11, 2020.
Pre-assignment details
In the Primary Cohort, participants with HER2 overexpressing gastric of GEJ adenocarcinoma were randomized (2:1) to either DS-8201a or physician's choice (irinotecan or paclitaxel). In the Exploratory Cohorts, participants with HER2 IHC 2+/ISH negative advanced gastric or GEJ adenocarcinoma who were naïve to HER2 treatment received DS-8201a.
Participants by arm
| Arm | Count |
|---|---|
| DS-8201a Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks. | 125 |
| Physician's Choice Irinotecan Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment. | 55 |
| Physician's Choice Paclitaxel Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment. | 7 |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks. | 20 |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks. | 24 |
| Total | 231 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 22 | 4 | 0 | 1 | 2 |
| Overall Study | Clinical progression | 7 | 4 | 1 | 1 | 1 |
| Overall Study | Death | 2 | 0 | 0 | 1 | 0 |
| Overall Study | Did not receive treatment | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Miscellaneous | 6 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 0 | 1 |
| Overall Study | Progressive disease per RECIST | 85 | 44 | 6 | 16 | 20 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | DS-8201a | Physician's Choice Irinotecan | Physician's Choice Paclitaxel | Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Exploratory: Naïve HER2 IHC 1+, DS-8201a | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 70 Participants | 31 Participants | 4 Participants | 9 Participants | 7 Participants | 121 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants | 24 Participants | 3 Participants | 11 Participants | 17 Participants | 110 Participants |
| Age, Continuous | 64.2 years STANDARD_DEVIATION 10.36 | 64.9 years STANDARD_DEVIATION 10.54 | 63.4 years STANDARD_DEVIATION 8.96 | 62.5 years STANDARD_DEVIATION 10.87 | 55.5 years STANDARD_DEVIATION 12.12 | 63.3 years STANDARD_DEVIATION 10.86 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 125 Participants | 55 Participants | 7 Participants | 20 Participants | 24 Participants | 231 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 99 participants | 44 participants | 6 participants | 16 participants | 19 participants | 184 participants |
| Region of Enrollment South Korea | 26 participants | 11 participants | 1 participants | 4 participants | 5 participants | 47 participants |
| Sex: Female, Male Female | 30 Participants | 13 Participants | 2 Participants | 4 Participants | 7 Participants | 56 Participants |
| Sex: Female, Male Male | 95 Participants | 42 Participants | 5 Participants | 16 Participants | 17 Participants | 175 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 98 / 125 | 46 / 55 | 4 / 7 | 50 / 62 | 16 / 20 | 21 / 24 |
| other Total, other adverse events | 125 / 125 | 54 / 55 | 7 / 7 | 61 / 62 | 20 / 20 | 24 / 24 |
| serious Total, serious adverse events | 58 / 125 | 15 / 55 | 1 / 7 | 16 / 62 | 6 / 20 | 11 / 24 |
Outcome results
Primary
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by independent central imaging review (ICR) based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Unconfirmed BOR (not confirmed by ICR) and confirmed BOR (confirmed by ICR) are reported.
Time frame: Baseline to date of first documented objective response, up to 36 months postdose
Population: Best overall response was assessed in the Primary Cohort in the Intent-to-Treat Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 41 Participants |
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 5 Participants |
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 15 Participants |
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 9 Participants |
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 4 Participants |
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 57 Participants |
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 10 Participants |
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 4 Participants |
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 3 Participants |
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 15 Participants |
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 10 Participants |
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 15 Participants |
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 55 Participants |
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 50 Participants |
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 51 Participants |
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 11 Participants |
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 41 Participants |
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 46 Participants |
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 15 Participants |
| DS-8201a | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 47 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 6 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 18 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 18 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 3 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 27 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 27 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 3 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 18 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 3 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 7 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 18 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 6 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 3 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 28 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 7 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 28 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 3 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 3 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 3 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 3 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 3 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 3 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 3 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 3 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 18 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 30 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 30 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 6 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 7 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 8 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 8 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 18 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 7 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 31 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 31 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 6 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 6 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 6 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 18 Participants |
| Physician's Choice Overall | Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 18 Participants |
Primary
Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by independent central imaging review (ICR) based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Unconfirmed ORR (not confirmed by ICR) and confirmed ORR (confirmed by ICR) are reported.
Time frame: Baseline to date of first documented objective response (CR or PR), up to 36 months postdose
Population: Objective response rate was assessed in the Primary Cohort in the Intent-to-Treat Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DS-8201a | Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed ORR, 36 months (DCO: Dec 11, 2020) | 50 Participants |
| DS-8201a | Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed ORR, 25 months (DCO: Nov 8, 2019) | 61 Participants |
| DS-8201a | Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed ORR, 36 months (DCO: Dec 11, 2020) | 61 Participants |
| DS-8201a | Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed ORR, 25 months (DCO: Nov 8, 2019) | 51 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed ORR, 25 months (DCO: Nov 8, 2019) | 7 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed ORR, 36 months (DCO: Dec 11, 2020) | 7 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed ORR, 25 months (DCO: Nov 8, 2019) | 6 Participants |
| Physician's Choice Irinotecan | Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed ORR, 36 months (DCO: Dec 11, 2020) | 6 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed ORR, 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed ORR, 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed ORR, 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Paclitaxel | Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed ORR, 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Overall | Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed ORR, 25 months (DCO: Nov 8, 2019) | 7 Participants |
| Physician's Choice Overall | Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed ORR, 25 months (DCO: Nov 8, 2019) | 8 Participants |
| Physician's Choice Overall | Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed ORR, 36 months (DCO: Dec 11, 2020) | 7 Participants |
| Physician's Choice Overall | Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Unconfirmed ORR, 36 months (DCO: Dec 11, 2020) | 8 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Disease control rate (DCR) was defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate. As per RECIST v1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Time frame: Baseline to date of first documented objective response (CR, PR, and SD), up to 36 months postdose
Population: Disease control rate (DCR) was assessed in the Intent-to-Treat Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DS-8201a | Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | DCR, 25 months (DCO: Nov 8, 2019) | 107 Participants |
| DS-8201a | Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | DCR, 36 months (DCO: Dec 11, 2020) | 108 Participants |
| Physician's Choice Irinotecan | Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | DCR, 25 months (DCO: Nov 8, 2019) | 34 Participants |
| Physician's Choice Irinotecan | Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | DCR, 36 months (DCO: Dec 11, 2020) | 34 Participants |
| Physician's Choice Paclitaxel | Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | DCR, 25 months (DCO: Nov 8, 2019) | 4 Participants |
| Physician's Choice Paclitaxel | Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | DCR, 36 months (DCO: Dec 11, 2020) | 4 Participants |
| Physician's Choice Overall | Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | DCR, 25 months (DCO: Nov 8, 2019) | 38 Participants |
| Physician's Choice Overall | Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | DCR, 36 months (DCO: Dec 11, 2020) | 38 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | DCR, 25 months (DCO: Nov 8, 2019) | 17 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | DCR, 36 months (DCO: Dec 11, 2020) | 17 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | DCR, 25 months (DCO: Nov 8, 2019) | 15 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | DCR, 36 months (DCO: Dec 11, 2020) | 15 Participants |
Secondary
Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set)
Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR was measured for responding subjects (PR or CR) only.
Time frame: From the date of first objective response (CR or PR) to the date of first documentation of PD or death (whichever occurs first), up to 36 months postdose
Population: Duration of response (DOR) was assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DS-8201a | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Unconfirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019) | 8.4 months |
| DS-8201a | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Confirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019) | 11.3 months |
| DS-8201a | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Confirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020) | 12.7 months |
| DS-8201a | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Unconfirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020) | 11.3 months |
| Physician's Choice Irinotecan | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Confirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019) | 4.1 months |
| Physician's Choice Irinotecan | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Unconfirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020) | 4.1 months |
| Physician's Choice Irinotecan | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Confirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020) | 4.1 months |
| Physician's Choice Irinotecan | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Unconfirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019) | 4.1 months |
| Physician's Choice Paclitaxel | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Confirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019) | 3.9 months |
| Physician's Choice Paclitaxel | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Unconfirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020) | 3.9 months |
| Physician's Choice Paclitaxel | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Confirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020) | 3.9 months |
| Physician's Choice Paclitaxel | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Unconfirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019) | 3.9 months |
| Physician's Choice Overall | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Unconfirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020) | 3.9 months |
| Physician's Choice Overall | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Confirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019) | 3.9 months |
| Physician's Choice Overall | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Confirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020) | 3.9 months |
| Physician's Choice Overall | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Unconfirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019) | 3.9 months |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Confirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019) | 7.6 months |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Unconfirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020) | 6.8 months |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Confirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020) | 7.6 months |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Unconfirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019) | 6.8 months |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Unconfirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019) | 7.1 months |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Unconfirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020) | 5.8 months |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Confirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020) | 11.2 months |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | Confirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019) | 12.5 months |
Secondary
Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Independent Central Review (ICR) based on RECIST version 1.1. The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by Investigator based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions). Confirmed ORR and BOR (confirmed by ICR) are reported.
Time frame: From randomization to first documented objective response, up to 36 months postdose
Population: Best overall response was assessed in the Exploratory Cohorts in the Intent-to-Treat Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DS-8201a | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019) | 5 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020) | 5 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 5 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 5 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 12 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 12 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 3 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 3 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Inevaluable, 25 months (DCO: Nov 8, 2019) | 1 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Inevaluable, 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Inevaluable, 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 13 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 6 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 13 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Inevaluable, 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 6 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 2 Participants |
Secondary
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Investigator based on RECIST version 1.1. The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by Investigator based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions). Unconfirmed ORR and BOR (not confirmed by Investigator) and confirmed ORR and BOR (confirmed by Investigator) are reported.
Time frame: From randomization to first documented objective response, up to 36 months postdose
Population: Objective response rate (ORR) and best overall response (BOR) were assessed in the Response Evaluable Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 53 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020) | 60 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 4 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 4 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 56 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 56 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 42 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 42 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 15 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 15 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 2 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 2 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019) | 49 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020) | 51 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 3 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 4 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 46 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 47 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019) | 60 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 51 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 15 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 15 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 2 Participants |
| DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 28 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 5 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020) | 5 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 16 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 27 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 7 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020) | 7 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 27 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019) | 7 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 15 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 16 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 28 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 15 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 7 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 5 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019) | 5 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Physician's Choice Irinotecan | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Paclitaxel | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 3 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 8 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 8 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 28 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 28 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 18 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 17 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 17 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 3 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 3 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019) | 6 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 3 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020) | 6 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 6 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 6 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 29 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 29 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019) | 8 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020) | 8 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 18 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Overall | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 8 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 7 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019) | 10 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 9 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 7 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 10 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020) | 10 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 8 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 10 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 9 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020) | 8 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019) | 8 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019) | 3 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 3 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 3 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 8 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020) | 8 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 10 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 8 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019) | 8 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 10 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020) | 8 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Partial response (PR), 25 months (DCO: Nov 8, 2019) | 5 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019) | 5 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019) | 8 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Partial response (PR), 36 months (DCO: Dec 11, 2020) | 5 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020) | 5 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Unconfirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020) | 3 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set) | Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020) | 0 Participants |
Secondary
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
Time frame: Baseline up to 47 days after last dose, up to 36 months postdose
Population: Adverse events were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with dose reduced, 25 months (DCO: Nov 8, 2019) | 40 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug interrupted, 36 months (DCO: Dec 11, 2020) | 79 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019) | 19 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020) | 23 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs, 36 months (DCO: Dec 11, 2020) | 122 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug interrupted, 25 months (DCO: Nov 8, 2019) | 78 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with dose reduced, 36 months (DCO: Dec 11, 2020) | 38 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019) | 12 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAE associated with drug interrupted, 36 months (DCO: Dec 11, 2020) | 65 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020) | 15 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with death, 25 months (DCO: Nov 8, 2019) | 8 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Serious TEAEs, 25 months (DCO: Nov 8, 2019) | 55 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs, 25 months (DCO: Nov 8, 2019) | 122 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with dose reduced, 25 months (DCO: Nov 8, 2019) | 38 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Serious TEAEs, 36 months (DCO: Dec 11, 2020) | 58 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with dose reduced, 36 months (DCO: Dec 11, 2020) | 40 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Any TEAE, 25 months (DCO: Nov 8, 2019) | 125 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related serious TEAEs, 25 months (DCO: Nov 8, 2019) | 27 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with death, 36 months (DCO: Dec 11, 2020) | 9 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Any TEAE, 36 months (DCO: Dec 11, 2020) | 125 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAE associated with drug interrupted, 25 months (DCO: Nov 8, 2019) | 64 Participants |
| DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related serious TEAEs, 36 months (DCO: Dec 11, 2020) | 31 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Any TEAE, 36 months (DCO: Dec 11, 2020) | 54 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug interrupted, 36 months (DCO: Dec 11, 2020) | 20 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with dose reduced, 36 months (DCO: Dec 11, 2020) | 21 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Serious TEAEs, 25 months (DCO: Nov 8, 2019) | 14 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019) | 4 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Any TEAE, 25 months (DCO: Nov 8, 2019) | 54 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with dose reduced, 25 months (DCO: Nov 8, 2019) | 21 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with death, 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug interrupted, 25 months (DCO: Nov 8, 2019) | 20 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAE associated with drug interrupted, 25 months (DCO: Nov 8, 2019) | 17 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020) | 4 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with dose reduced, 25 months (DCO: Nov 8, 2019) | 21 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs, 36 months (DCO: Dec 11, 2020) | 51 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related serious TEAEs, 36 months (DCO: Dec 11, 2020) | 5 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAE associated with drug interrupted, 36 months (DCO: Dec 11, 2020) | 17 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related serious TEAEs, 25 months (DCO: Nov 8, 2019) | 5 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019) | 3 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Serious TEAEs, 36 months (DCO: Dec 11, 2020) | 15 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with death, 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with dose reduced, 36 months (DCO: Dec 11, 2020) | 21 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs, 25 months (DCO: Nov 8, 2019) | 51 Participants |
| Physician's Choice Irinotecan | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020) | 3 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAE associated with drug interrupted, 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with dose reduced, 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with dose reduced, 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with dose reduced, 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs, 25 months (DCO: Nov 8, 2019) | 5 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with death, 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs, 36 months (DCO: Dec 11, 2020) | 5 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Serious TEAEs, 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with death, 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAE associated with drug interrupted, 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Serious TEAEs, 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related serious TEAEs, 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug interrupted, 36 months (DCO: Dec 11, 2020) | 3 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related serious TEAEs, 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Any TEAE, 36 months (DCO: Dec 11, 2020) | 7 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug interrupted, 25 months (DCO: Nov 8, 2019) | 3 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Any TEAE, 25 months (DCO: Nov 8, 2019) | 7 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with dose reduced, 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Paclitaxel | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Serious TEAEs, 36 months (DCO: Dec 11, 2020) | 16 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Any TEAE, 25 months (DCO: Nov 8, 2019) | 61 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Any TEAE, 36 months (DCO: Dec 11, 2020) | 61 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs, 25 months (DCO: Nov 8, 2019) | 56 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs, 36 months (DCO: Dec 11, 2020) | 56 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Serious TEAEs, 25 months (DCO: Nov 8, 2019) | 15 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related serious TEAEs, 25 months (DCO: Nov 8, 2019) | 5 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related serious TEAEs, 36 months (DCO: Dec 11, 2020) | 5 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019) | 4 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020) | 4 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019) | 3 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020) | 3 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with dose reduced, 25 months (DCO: Nov 8, 2019) | 21 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with dose reduced, 36 months (DCO: Dec 11, 2020) | 21 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with dose reduced, 25 months (DCO: Nov 8, 2019) | 21 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with dose reduced, 36 months (DCO: Dec 11, 2020) | 21 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug interrupted, 25 months (DCO: Nov 8, 2019) | 23 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug interrupted, 36 months (DCO: Dec 11, 2020) | 23 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAE associated with drug interrupted, 25 months (DCO: Nov 8, 2019) | 19 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAE associated with drug interrupted, 36 months (DCO: Dec 11, 2020) | 19 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with death, 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Physician's Choice Overall | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with death, 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with dose reduced, 36 months (DCO: Dec 11, 2020) | 6 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Any TEAE, 25 months (DCO: Nov 8, 2019) | 20 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug interrupted, 25 months (DCO: Nov 8, 2019) | 8 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related serious TEAEs, 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with death, 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug interrupted, 36 months (DCO: Dec 11, 2020) | 8 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related serious TEAEs, 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Serious TEAEs, 36 months (DCO: Dec 11, 2020) | 6 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAE associated with drug interrupted, 25 months (DCO: Nov 8, 2019) | 7 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Serious TEAEs, 25 months (DCO: Nov 8, 2019) | 6 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAE associated with drug interrupted, 36 months (DCO: Dec 11, 2020) | 7 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs, 36 months (DCO: Dec 11, 2020) | 19 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs, 25 months (DCO: Nov 8, 2019) | 19 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with death, 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with dose reduced, 36 months (DCO: Dec 11, 2020) | 6 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with dose reduced, 25 months (DCO: Nov 8, 2019) | 6 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Any TEAE, 36 months (DCO: Dec 11, 2020) | 20 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with dose reduced, 25 months (DCO: Nov 8, 2019) | 6 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with dose reduced, 25 months (DCO: Nov 8, 2019) | 7 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Any TEAE, 25 months (DCO: Nov 8, 2019) | 24 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAE associated with drug interrupted, 25 months (DCO: Nov 8, 2019) | 10 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with dose reduced, 36 months (DCO: Dec 11, 2020) | 7 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Serious TEAEs, 25 months (DCO: Nov 8, 2019) | 11 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with death, 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs, 36 months (DCO: Dec 11, 2020) | 24 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Any TEAE, 36 months (DCO: Dec 11, 2020) | 24 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug interrupted, 25 months (DCO: Nov 8, 2019) | 10 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related serious TEAEs, 36 months (DCO: Dec 11, 2020) | 6 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAE associated with drug interrupted, 36 months (DCO: Dec 11, 2020) | 10 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related serious TEAEs, 25 months (DCO: Nov 8, 2019) | 6 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Drug-related TEAEs, 25 months (DCO: Nov 8, 2019) | 24 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with drug interrupted, 36 months (DCO: Dec 11, 2020) | 10 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with dose reduced, 36 months (DCO: Dec 11, 2020) | 8 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | Serious TEAEs, 36 months (DCO: Dec 11, 2020) | 11 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with dose reduced, 25 months (DCO: Nov 8, 2019) | 8 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set) | TEAEs associated with death, 36 months (DCO: Dec 11, 2020) | 0 Participants |
Secondary
Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Duration of survival follow-up (months) was defined as the date of last contact - date of randomization/ registration + 1.Overall Survival (OS) was defined as the time from the date of randomization (the date of the registration for the Exploratory Cohorts) to the date of death due to any cause.
Time frame: From the date of randomization to the date of death (due to any cause), up to 36 months postdose
Population: Duration of survival and overall survival were assessed in the Intent-to-Treat Analysis Set.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DS-8201a | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Duration of survival follow up, 25 months (DCO: Nov 8, 2019) | 8.0 months |
| DS-8201a | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Duration of survival follow up, 36 months (DCO: Dec 11, 2020) | 12.3 months |
| DS-8201a | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Overall survival, 25 months (DCO: Nov 8, 2019) | 12.5 months |
| DS-8201a | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Overall survival, 36 months (DCO: Dec 11, 2020) | 12.6 months |
| Physician's Choice Irinotecan | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Overall survival, 25 months (DCO: Nov 8, 2019) | 8.4 months |
| Physician's Choice Irinotecan | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Duration of survival follow up, 36 months (DCO: Dec 11, 2020) | 8.4 months |
| Physician's Choice Irinotecan | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Duration of survival follow up, 25 months (DCO: Nov 8, 2019) | 7.1 months |
| Physician's Choice Irinotecan | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Overall survival, 36 months (DCO: Dec 11, 2020) | 8.6 months |
| Physician's Choice Paclitaxel | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Overall survival, 36 months (DCO: Dec 11, 2020) | 14.3 months |
| Physician's Choice Paclitaxel | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Overall survival, 25 months (DCO: Nov 8, 2019) | 14.3 months |
| Physician's Choice Paclitaxel | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Duration of survival follow up, 36 months (DCO: Dec 11, 2020) | 14.3 months |
| Physician's Choice Paclitaxel | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Duration of survival follow up, 25 months (DCO: Nov 8, 2019) | 5.5 months |
| Physician's Choice Overall | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Duration of survival follow up, 25 months (DCO: Nov 8, 2019) | 7.0 months |
| Physician's Choice Overall | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Overall survival, 36 months (DCO: Dec 11, 2020) | 8.9 months |
| Physician's Choice Overall | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Duration of survival follow up, 36 months (DCO: Dec 11, 2020) | 8.5 months |
| Physician's Choice Overall | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Overall survival, 25 months (DCO: Nov 8, 2019) | 8.4 months |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Overall survival, 25 months (DCO: Nov 8, 2019) | 7.8 months |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Overall survival, 36 months (DCO: Dec 11, 2020) | 7.8 months |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Duration of survival follow up, 36 months (DCO: Dec 11, 2020) | 7.3 months |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Duration of survival follow up, 25 months (DCO: Nov 8, 2019) | 7.3 months |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Duration of survival follow up, 36 months (DCO: Dec 11, 2020) | 8.5 months |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Overall survival, 25 months (DCO: Nov 8, 2019) | 8.5 months |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Overall survival, 36 months (DCO: Dec 11, 2020) | 8.5 months |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | Duration of survival follow up, 25 months (DCO: Nov 8, 2019) | 8.4 months |
Secondary
Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The maximum serum concentration (Cmax) and the trough serum concentration (Ctrough) of DS-8201a were assessed. These serum PK parameters for DS-8201a and total anti-HER2 antibody were estimated in each participant using standard noncompartmental methods.
Time frame: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DS-8201a | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Cmax: DS-8201a, Cycle 1 | 127 ug/mL | Standard Deviation 28.4 |
| DS-8201a | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Cmax: Total Anti-HER2 antibody, Cycle 1 | 116 ug/mL | Standard Deviation 30.6 |
| DS-8201a | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Cmax: Total Anti-HER2 antibody, Cycle 3 | 121 ug/mL | Standard Deviation 28.4 |
| DS-8201a | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Ctrough: DS-8201a, Cycle 1 | 5.56 ug/mL | Standard Deviation 3.08 |
| DS-8201a | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Ctrough: DS-8201a, Cycle 3 | 13.4 ug/mL | Standard Deviation 17.3 |
| DS-8201a | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Ctrough: Total Anti-HER2 antibody, Cycle 1 | 8.56 ug/mL | Standard Deviation 8.6 |
| DS-8201a | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Cmax: DS-8201a, Cycle 3 | 137 ug/mL | Standard Deviation 31.1 |
| DS-8201a | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Ctrough: Total Anti-HER2 antibody, Cycle 3 | 15.6 ug/mL | Standard Deviation 13.6 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Ctrough: DS-8201a, Cycle 1 | 4.52 ug/mL | Standard Deviation 2.42 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Cmax: DS-8201a, Cycle 1 | 119 ug/mL | Standard Deviation 29.1 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Cmax: Total Anti-HER2 antibody, Cycle 3 | 115 ug/mL | Standard Deviation 24.2 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Cmax: DS-8201a, Cycle 3 | 128 ug/mL | Standard Deviation 25.6 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Ctrough: Total Anti-HER2 antibody, Cycle 3 | 12.2 ug/mL | Standard Deviation 5.76 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Ctrough: DS-8201a, Cycle 3 | 8.84 ug/mL | Standard Deviation 3.09 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Cmax: Total Anti-HER2 antibody, Cycle 1 | 105 ug/mL | Standard Deviation 26.1 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Ctrough: Total Anti-HER2 antibody, Cycle 1 | 5.33 ug/mL | Standard Deviation 2.97 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Cmax: Total Anti-HER2 antibody, Cycle 1 | 110 ug/mL | Standard Deviation 19.6 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Cmax: Total Anti-HER2 antibody, Cycle 3 | 112 ug/mL | Standard Deviation 21.9 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Ctrough: DS-8201a, Cycle 1 | 9.51 ug/mL | Standard Deviation 23.4 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Ctrough: Total Anti-HER2 antibody, Cycle 3 | 14.6 ug/mL | Standard Deviation 17.6 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Ctrough: DS-8201a, Cycle 3 | 13.2 ug/mL | Standard Deviation 18.6 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Cmax: DS-8201a, Cycle 1 | 127 ug/mL | Standard Deviation 24.5 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Cmax: DS-8201a, Cycle 3 | 123 ug/mL | Standard Deviation 23.2 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | Ctrough: Total Anti-HER2 antibody, Cycle 1 | 10.0 ug/mL | Standard Deviation 20.5 |
Secondary
Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The maximum serum concentration (Cmax) and the trough serum concentration (Ctrough) of DS-8201a were assessed. These serum PK parameters for MAAA-1181a were estimated in each participant using standard noncompartmental methods.
Time frame: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DS-8201a | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a | Ctrough: MAAA-1181a Cycle 3 | 0.714 ng/mL | Standard Deviation 2.19 |
| DS-8201a | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a | Cmax: MAAA-1181a, Cycle 3 | 9.08 ng/mL | Standard Deviation 3.81 |
| DS-8201a | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a | Cmax: MAAA-1181a, Cycle 1 | 12.1 ng/mL | Standard Deviation 4.79 |
| DS-8201a | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a | Ctrough: MAAA-1181a, Cycle 1 | 0.316 ng/mL | Standard Deviation 0.294 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a | Ctrough: MAAA-1181a Cycle 3 | 0.378 ng/mL | Standard Deviation 0.138 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a | Ctrough: MAAA-1181a, Cycle 1 | 0.290 ng/mL | Standard Deviation 0.237 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a | Cmax: MAAA-1181a, Cycle 3 | 7.62 ng/mL | Standard Deviation 1.86 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a | Cmax: MAAA-1181a, Cycle 1 | 13.3 ng/mL | Standard Deviation 8.52 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a | Ctrough: MAAA-1181a, Cycle 1 | 0.772 ng/mL | Standard Deviation 2.28 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a | Cmax: MAAA-1181a, Cycle 3 | 9.83 ng/mL | Standard Deviation 3.75 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a | Cmax: MAAA-1181a, Cycle 1 | 13.3 ng/mL | Standard Deviation 7.37 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a | Ctrough: MAAA-1181a Cycle 3 | 1.10 ng/mL | Standard Deviation 1.95 |
Secondary
Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The time to maximum serum concentration (Tmax) of DS-8201a was assessed. This serum PK parameter for DS-8201a, total anti-HER2 antibody, and MAAA-1181a were estimated in each participant using standard noncompartmental methods.
Time frame: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DS-8201a | Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | DS-8201a, Cycle 1 | 3.93 hours |
| DS-8201a | Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | Total Anti-HER2 antibody, Cycle 3 | 3.98 hours |
| DS-8201a | Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | MAAA-1181a, Cycle 3 | 6.80 hours |
| DS-8201a | Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | DS-8201a, Cycle 3 | 4.00 hours |
| DS-8201a | Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | MAAA-1181a, Cycle 1 | 6.85 hours |
| DS-8201a | Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | Total Anti-HER2 antibody, Cycle 1 | 3.83 hours |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | MAAA-1181a, Cycle 1 | 6.83 hours |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | MAAA-1181a, Cycle 3 | 6.82 hours |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | Total Anti-HER2 antibody, Cycle 1 | 3.83 hours |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | DS-8201a, Cycle 1 | 3.90 hours |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | DS-8201a, Cycle 3 | 4.00 hours |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | Total Anti-HER2 antibody, Cycle 3 | 4.00 hours |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | Total Anti-HER2 antibody, Cycle 3 | 3.75 hours |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | DS-8201a, Cycle 3 | 4.00 hours |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | Total Anti-HER2 antibody, Cycle 1 | 3.87 hours |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | DS-8201a, Cycle 1 | 3.89 hours |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | MAAA-1181a, Cycle 1 | 6.81 hours |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | MAAA-1181a, Cycle 3 | 6.77 hours |
Secondary
Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Area under the concentration versus time curve (AUC) from Time 0 to the Last Quantifiable Concentration (AUClast) and Area Under the Concentration versus-Time Curve up to 21 days (AUC21d) are reported. These serum PK parameters for DS-8201a and total anti-HER2 antibody were estimated in each participant using standard noncompartmental methods.
Time frame: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. No patient samples were collected or analyzed for AUClast DS-8201a and total anti-HER2 antibody for Cycle 3 as AUClast was planned to be assessed only for Cycle 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DS-8201a | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | AUClast: DS-8201a, Cycle 1 | 611 ug*d/mL | Standard Deviation 150 |
| DS-8201a | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | AUClast: Total Anti-HER2 antibody, Cycle 1 | 667 ug*d/mL | Standard Deviation 241 |
| DS-8201a | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | AUC21d: Total Anti-HER2 antibody, Cycle 1 | 651 ug*d/mL | Standard Deviation 210 |
| DS-8201a | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | AUC21d: Total Anti-HER2 antibody, Cycle 3 | 888 ug*d/mL | Standard Deviation 244 |
| DS-8201a | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | AUC21d: DS-8201a, Cycle 1 | 612 ug*d/mL | Standard Deviation 150 |
| DS-8201a | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | AUC21d: DS-8201a, Cycle 3 | 867 ug*d/mL | Standard Deviation 213 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | AUC21d: DS-8201a, Cycle 3 | 746 ug*d/mL | Standard Deviation 197 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | AUClast: DS-8201a, Cycle 1 | 572 ug*d/mL | Standard Deviation 143 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | AUC21d: Total Anti-HER2 antibody, Cycle 3 | 775 ug*d/mL | Standard Deviation 210 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | AUC21d: Total Anti-HER2 antibody, Cycle 1 | 570 ug*d/mL | Standard Deviation 126 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | AUClast: Total Anti-HER2 antibody, Cycle 1 | 570 ug*d/mL | Standard Deviation 126 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | AUC21d: DS-8201a, Cycle 1 | 572 ug*d/mL | Standard Deviation 143 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | AUClast: Total Anti-HER2 antibody, Cycle 1 | 547 ug*d/mL | Standard Deviation 167 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | AUC21d: DS-8201a, Cycle 1 | 569 ug*d/mL | Standard Deviation 114 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | AUC21d: DS-8201a, Cycle 3 | 724 ug*d/mL | Standard Deviation 71.9 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | AUC21d: Total Anti-HER2 antibody, Cycle 1 | 582 ug*d/mL | Standard Deviation 104 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | AUClast: DS-8201a, Cycle 1 | 545 ug*d/mL | Standard Deviation 160 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a | AUC21d: Total Anti-HER2 antibody, Cycle 3 | 737 ug*d/mL | Standard Deviation 110 |
Secondary
Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of MAAA-1181 Following Treatment With DS-8201a
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Area under the concentration versus time curve (AUC) from Time 0 to the Last Quantifiable Concentration (AUClast) and Area Under the Concentration versus-Time Curve up to 21 days (AUC21d) are reported. These serum PK parameters for MAAA-1181a were estimated in each participant using standard noncompartmental methods.
Time frame: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. No patient samples were collected or analyzed for MAAA-1181a for Cycle 3 as AUClast was planned to be assessed only for Cycle 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DS-8201a | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of MAAA-1181 Following Treatment With DS-8201a | AUC21d: MAAA-1181a, Cycle 1 | 46.4 ng*d/mL | Standard Deviation 16.1 |
| DS-8201a | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of MAAA-1181 Following Treatment With DS-8201a | AUClast: MAAA-1181a, Cycle 1 | 46.7 ng*d/mL | Standard Deviation 16.3 |
| DS-8201a | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of MAAA-1181 Following Treatment With DS-8201a | AUC21d: MAAA-1181a, Cycle 3 | 42.0 ng*d/mL | Standard Deviation 15.1 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of MAAA-1181 Following Treatment With DS-8201a | AUC21d: MAAA-1181a, Cycle 1 | 44.9 ng*d/mL | Standard Deviation 20.1 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of MAAA-1181 Following Treatment With DS-8201a | AUClast: MAAA-1181a, Cycle 1 | 53.4 ng*d/mL | Standard Deviation 42.7 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of MAAA-1181 Following Treatment With DS-8201a | AUC21d: MAAA-1181a, Cycle 3 | 39.4 ng*d/mL | Standard Deviation 8.36 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of MAAA-1181 Following Treatment With DS-8201a | AUClast: MAAA-1181a, Cycle 1 | 44.5 ng*d/mL | Standard Deviation 22.5 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of MAAA-1181 Following Treatment With DS-8201a | AUC21d: MAAA-1181a, Cycle 3 | 44.6 ng*d/mL | Standard Deviation 17.8 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of MAAA-1181 Following Treatment With DS-8201a | AUC21d: MAAA-1181a, Cycle 1 | 44.5 ng*d/mL | Standard Deviation 22.5 |
Secondary
Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Terminal elimination half-life (t1/2) of DS-8201a was assessed. This serum PK parameter for DS-8201a, total anti-HER2 antibody, and MAAA-1181a were estimated in each participant using standard noncompartmental methods.
Time frame: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)
Population: Pharmacokinetic parameters were assessed in patients with available data in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DS-8201a | Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | DS-8201a, Cycle 1 | 5.77 days | Standard Deviation 1.37 |
| DS-8201a | Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | DS-8201a, Cycle 3 | 7.46 days | Standard Deviation 1.82 |
| DS-8201a | Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | Total Anti-HER2 antibody, Cycle 1 | 6.20 days | Standard Deviation 2.22 |
| DS-8201a | Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | Total Anti-HER2 antibody, Cycle 3 | 8.00 days | Standard Deviation 2.04 |
| DS-8201a | Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | MAAA-1181a, Cycle 1 | 5.50 days | Standard Deviation 1.11 |
| DS-8201a | Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | MAAA-1181a, Cycle 3 | 7.01 days | Standard Deviation 1.65 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | MAAA-1181a, Cycle 3 | 6.18 days | Standard Deviation 1.02 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | DS-8201a, Cycle 1 | 5.54 days | Standard Deviation 1.08 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | Total Anti-HER2 antibody, Cycle 3 | 7.90 days | Standard Deviation 2.1 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | MAAA-1181a, Cycle 1 | 5.21 days | Standard Deviation 0.939 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | DS-8201a, Cycle 3 | 6.40 days | Standard Deviation 1 |
| Physician's Choice Irinotecan | Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | Total Anti-HER2 antibody, Cycle 1 | 5.54 days | Standard Deviation 1.01 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | DS-8201a, Cycle 3 | 6.35 days | Standard Deviation 1.73 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | Total Anti-HER2 antibody, Cycle 1 | 5.65 days | Standard Deviation 1.51 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | MAAA-1181a, Cycle 3 | 5.80 days | Standard Deviation 1.1 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | Total Anti-HER2 antibody, Cycle 3 | 6.17 days | Standard Deviation 1.15 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | DS-8201a, Cycle 1 | 5.52 days | Standard Deviation 1.17 |
| Physician's Choice Paclitaxel | Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a | MAAA-1181a, Cycle 1 | 5.61 days | Standard Deviation 1.19 |
Secondary
Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Progression-free survival (PFS) was defined as the time from the date of randomization (the date of the registration for the Exploratory Cohorts) to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions.
Time frame: From the date of randomization to the first documented disease progression or date of death (whichever occurs first), up to 36 months postdose
Population: Progression-free survival (PFS) was assessed in the Intent-to-Treat Analysis Set.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DS-8201a | Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | PFS, 25 months (DCO: Nov 8, 2019) | 5.6 months |
| DS-8201a | Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | PFS, 36 months (DCO: Dec 11, 2020) | 5.6 months |
| Physician's Choice Irinotecan | Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | PFS, 25 months (DCO: Nov 8, 2019) | 2.8 months |
| Physician's Choice Irinotecan | Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | PFS, 36 months (DCO: Dec 11, 2020) | 2.8 months |
| Physician's Choice Paclitaxel | Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | PFS, 25 months (DCO: Nov 8, 2019) | 4.9 months |
| Physician's Choice Paclitaxel | Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | PFS, 36 months (DCO: Dec 11, 2020) | 4.9 months |
| Physician's Choice Overall | Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | PFS, 25 months (DCO: Nov 8, 2019) | 3.5 months |
| Physician's Choice Overall | Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | PFS, 36 months (DCO: Dec 11, 2020) | 3.5 months |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | PFS, 25 months (DCO: Nov 8, 2019) | 4.4 months |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | PFS, 36 months (DCO: Dec 11, 2020) | 4.4 months |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | PFS, 25 months (DCO: Nov 8, 2019) | 2.8 months |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) | PFS, 36 months (DCO: Dec 11, 2020) | 2.8 months |
Secondary
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Time frame: Baseline up to 47 days after last dose, up to 36 months postdose
Population: Adverse events were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Pyrexia, 25 months (DCO: Nov 8, 2019) | 30 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Constipation, 36 months (DCO: Dec 11, 2020) | 31 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Malaise, 25 months (DCO: Nov 8, 2019) | 43 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Constipation, 25 months (DCO: Nov 8, 2019) | 30 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Malaise, 36 months (DCO: Dec 11, 2020) | 44 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Dysgeusia, 36 months (DCO: Dec 11, 2020) | 9 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Vomiting, 36 months (DCO: Dec 11, 2020) | 33 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Vomiting, 25 months (DCO: Nov 8, 2019) | 33 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Diarrhoea, 36 months (DCO: Dec 11, 2020) | 41 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Nausea, 36 months (DCO: Dec 11, 2020) | 79 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Diarrhoea, 25 months (DCO: Nov 8, 2019) | 40 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Dysgeusia, 25 months (DCO: Nov 8, 2019) | 9 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Oedema peripheral, 36 months (DCO: Dec 11, 2020) | 15 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Decreased appetite, 25 months (DCO: Nov 8, 2019) | 75 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Oedema peripheral, 25 months (DCO: Nov 8, 2019) | 13 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Decreased appetite, 36 months (DCO: Dec 11, 2020) | 76 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Any TEAE, 36 months (DCO: Dec 11, 2020) | 125 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Hypoalbuminaemia, 36 months (DCO: Dec 11, 2020) | 18 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Hypoalbuminaemia, 25 months (DCO: Nov 8, 2019) | 18 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Neutrophil count decreased, 25 months (DCO: Nov 8, 2019) | 77 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Weight decreased, 36 months (DCO: Dec 11, 2020) | 19 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Neutrophil count decreased, 36 months (DCO: Dec 11, 2020) | 79 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Any TEAE, 25 months (DCO: Nov 8, 2019) | 125 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Weight decreased, 25 months (DCO: Nov 8, 2019) | 17 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Anaemia, 25 months (DCO: Nov 8, 2019) | 71 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Peripheral sensory neuropathy, 36 months (DCO: Dec 11, 2020) | 4 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Lymphocyte count decreased, 36 months (DCO: Dec 11, 2020) | 30 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Anaemia, 36 months (DCO: Dec 11, 2020) | 71 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Lymphocyte count decreased, 25 months (DCO: Nov 8, 2019) | 27 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Alopecia, 36 months (DCO: Dec 11, 2020) | 28 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | White blood cell count decreased, 25 months (DCO: Nov 8, 2019) | 47 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Peripheral sensory neuropathy, 25 months (DCO: Nov 8, 2019) | 4 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Alopecia, 25 months (DCO: Nov 8, 2019) | 28 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | White blood cell count decreased, 36 months (DCO: Dec 11, 2020) | 49 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Nausea, 25 months (DCO: Nov 8, 2019) | 79 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Fatigue, 36 months (DCO: Dec 11, 2020) | 27 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Fatigue, 25 months (DCO: Nov 8, 2019) | 27 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Platelet count decreased, 25 months (DCO: Nov 8, 2019) | 47 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Pyrexia, 36 months (DCO: Dec 11, 2020) | 31 Participants |
| DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Platelet count decreased, 36 months (DCO: Dec 11, 2020) | 48 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | White blood cell count decreased, 25 months (DCO: Nov 8, 2019) | 18 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Constipation, 36 months (DCO: Dec 11, 2020) | 13 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Diarrhoea, 25 months (DCO: Nov 8, 2019) | 20 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Neutrophil count decreased, 36 months (DCO: Dec 11, 2020) | 18 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Malaise, 25 months (DCO: Nov 8, 2019) | 9 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Dysgeusia, 36 months (DCO: Dec 11, 2020) | 4 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Constipation, 25 months (DCO: Nov 8, 2019) | 13 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Any TEAE, 25 months (DCO: Nov 8, 2019) | 54 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Vomiting, 36 months (DCO: Dec 11, 2020) | 5 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Alopecia, 25 months (DCO: Nov 8, 2019) | 8 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Malaise, 36 months (DCO: Dec 11, 2020) | 9 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Weight decreased, 25 months (DCO: Nov 8, 2019) | 5 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Platelet count decreased, 25 months (DCO: Nov 8, 2019) | 4 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Vomiting, 25 months (DCO: Nov 8, 2019) | 5 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Fatigue, 36 months (DCO: Dec 11, 2020) | 15 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Dysgeusia, 25 months (DCO: Nov 8, 2019) | 4 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Diarrhoea, 36 months (DCO: Dec 11, 2020) | 20 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Anaemia, 25 months (DCO: Nov 8, 2019) | 17 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Nausea, 25 months (DCO: Nov 8, 2019) | 27 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Nausea, 36 months (DCO: Dec 11, 2020) | 27 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Lymphocyte count decreased, 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | White blood cell count decreased, 36 months (DCO: Dec 11, 2020) | 18 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Oedema peripheral, 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Lymphocyte count decreased, 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Pyrexia, 36 months (DCO: Dec 11, 2020) | 8 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Decreased appetite, 25 months (DCO: Nov 8, 2019) | 27 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Peripheral sensory neuropathy, 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Oedema peripheral, 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Anaemia, 36 months (DCO: Dec 11, 2020) | 17 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Hypoalbuminaemia, 36 months (DCO: Dec 11, 2020) | 7 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Peripheral sensory neuropathy, 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Decreased appetite, 36 months (DCO: Dec 11, 2020) | 27 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Platelet count decreased, 36 months (DCO: Dec 11, 2020) | 4 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Alopecia, 36 months (DCO: Dec 11, 2020) | 8 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Hypoalbuminaemia, 25 months (DCO: Nov 8, 2019) | 7 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Fatigue, 25 months (DCO: Nov 8, 2019) | 15 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Pyrexia, 25 months (DCO: Nov 8, 2019) | 8 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Neutrophil count decreased, 25 months (DCO: Nov 8, 2019) | 18 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Any TEAE, 36 months (DCO: Dec 11, 2020) | 54 Participants |
| Physician's Choice Irinotecan | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Weight decreased, 36 months (DCO: Dec 11, 2020) | 5 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Weight decreased, 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Any TEAE, 25 months (DCO: Nov 8, 2019) | 7 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Any TEAE, 36 months (DCO: Dec 11, 2020) | 7 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Nausea, 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Nausea, 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Decreased appetite, 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Decreased appetite, 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Neutrophil count decreased, 25 months (DCO: Nov 8, 2019) | 3 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Neutrophil count decreased, 36 months (DCO: Dec 11, 2020) | 3 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Anaemia, 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Anaemia, 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | White blood cell count decreased, 25 months (DCO: Nov 8, 2019) | 3 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | White blood cell count decreased, 36 months (DCO: Dec 11, 2020) | 3 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Platelet count decreased, 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Platelet count decreased, 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Malaise, 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Malaise, 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Diarrhoea, 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Diarrhoea, 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Vomiting, 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Vomiting, 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Constipation, 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Constipation, 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Pyrexia, 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Pyrexia, 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Fatigue, 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Fatigue, 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Alopecia, 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Alopecia, 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Lymphocyte count decreased, 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Lymphocyte count decreased, 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Weight decreased, 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Hypoalbuminaemia, 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Oedema peripheral, 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Oedema peripheral, 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Dysgeusia, 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Dysgeusia, 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Peripheral sensory neuropathy, 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Peripheral sensory neuropathy, 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Physician's Choice Paclitaxel | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Hypoalbuminaemia, 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Oedema peripheral, 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Constipation, 36 months (DCO: Dec 11, 2020) | 15 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Platelet count decreased, 36 months (DCO: Dec 11, 2020) | 4 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Pyrexia, 25 months (DCO: Nov 8, 2019) | 10 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Platelet count decreased, 25 months (DCO: Nov 8, 2019) | 4 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Pyrexia, 36 months (DCO: Dec 11, 2020) | 10 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Fatigue, 25 months (DCO: Nov 8, 2019) | 15 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | White blood cell count decreased, 36 months (DCO: Dec 11, 2020) | 21 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Fatigue, 36 months (DCO: Dec 11, 2020) | 15 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | White blood cell count decreased, 25 months (DCO: Nov 8, 2019) | 21 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Peripheral sensory neuropathy, 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Alopecia, 25 months (DCO: Nov 8, 2019) | 9 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Alopecia, 36 months (DCO: Dec 11, 2020) | 9 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Anaemia, 36 months (DCO: Dec 11, 2020) | 19 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Lymphocyte count decreased, 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Anaemia, 25 months (DCO: Nov 8, 2019) | 19 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Any TEAE, 36 months (DCO: Dec 11, 2020) | 61 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Lymphocyte count decreased, 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Neutrophil count decreased, 36 months (DCO: Dec 11, 2020) | 21 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Weight decreased, 25 months (DCO: Nov 8, 2019) | 5 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Neutrophil count decreased, 25 months (DCO: Nov 8, 2019) | 21 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Weight decreased, 36 months (DCO: Dec 11, 2020) | 5 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Any TEAE, 25 months (DCO: Nov 8, 2019) | 61 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Hypoalbuminaemia, 25 months (DCO: Nov 8, 2019) | 8 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Decreased appetite, 36 months (DCO: Dec 11, 2020) | 28 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Hypoalbuminaemia, 36 months (DCO: Dec 11, 2020) | 8 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Decreased appetite, 25 months (DCO: Nov 8, 2019) | 28 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Peripheral sensory neuropathy, 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Oedema peripheral, 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Constipation, 25 months (DCO: Nov 8, 2019) | 14 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Nausea, 36 months (DCO: Dec 11, 2020) | 29 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Dysgeusia, 25 months (DCO: Nov 8, 2019) | 4 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Diarrhoea, 25 months (DCO: Nov 8, 2019) | 20 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Diarrhoea, 36 months (DCO: Dec 11, 2020) | 20 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Nausea, 25 months (DCO: Nov 8, 2019) | 29 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Vomiting, 25 months (DCO: Nov 8, 2019) | 5 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Malaise, 36 months (DCO: Dec 11, 2020) | 10 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Vomiting, 36 months (DCO: Dec 11, 2020) | 5 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Malaise, 25 months (DCO: Nov 8, 2019) | 10 Participants |
| Physician's Choice Overall | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Dysgeusia, 36 months (DCO: Dec 11, 2020) | 4 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Pyrexia, 36 months (DCO: Dec 11, 2020) | 3 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Peripheral sensory neuropathy, 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Alopecia, 36 months (DCO: Dec 11, 2020) | 3 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Lymphocyte count decreased, 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Anaemia, 25 months (DCO: Nov 8, 2019) | 10 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Dysgeusia, 25 months (DCO: Nov 8, 2019) | 4 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Lymphocyte count decreased, 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Neutrophil count decreased, 36 months (DCO: Dec 11, 2020) | 8 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Diarrhoea, 25 months (DCO: Nov 8, 2019) | 6 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Weight decreased, 25 months (DCO: Nov 8, 2019) | 4 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Nausea, 25 months (DCO: Nov 8, 2019) | 11 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Weight decreased, 36 months (DCO: Dec 11, 2020) | 4 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Decreased appetite, 36 months (DCO: Dec 11, 2020) | 13 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Neutrophil count decreased, 25 months (DCO: Nov 8, 2019) | 8 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Diarrhoea, 36 months (DCO: Dec 11, 2020) | 6 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Hypoalbuminaemia, 25 months (DCO: Nov 8, 2019) | 2 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Hypoalbuminaemia, 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Decreased appetite, 25 months (DCO: Nov 8, 2019) | 13 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Constipation, 25 months (DCO: Nov 8, 2019) | 5 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Platelet count decreased, 36 months (DCO: Dec 11, 2020) | 3 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Dysgeusia, 36 months (DCO: Dec 11, 2020) | 4 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Malaise, 36 months (DCO: Dec 11, 2020) | 4 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Constipation, 36 months (DCO: Dec 11, 2020) | 5 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Malaise, 25 months (DCO: Nov 8, 2019) | 4 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Vomiting, 36 months (DCO: Dec 11, 2020) | 4 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Pyrexia, 25 months (DCO: Nov 8, 2019) | 3 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Platelet count decreased, 25 months (DCO: Nov 8, 2019) | 3 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Oedema peripheral, 25 months (DCO: Nov 8, 2019) | 4 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Anaemia, 36 months (DCO: Dec 11, 2020) | 10 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | White blood cell count decreased, 36 months (DCO: Dec 11, 2020) | 4 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Any TEAE, 36 months (DCO: Dec 11, 2020) | 20 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Fatigue, 25 months (DCO: Nov 8, 2019) | 5 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Nausea, 36 months (DCO: Dec 11, 2020) | 11 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Any TEAE, 25 months (DCO: Nov 8, 2019) | 20 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Peripheral sensory neuropathy, 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Fatigue, 36 months (DCO: Dec 11, 2020) | 5 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | White blood cell count decreased, 25 months (DCO: Nov 8, 2019) | 4 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Vomiting, 25 months (DCO: Nov 8, 2019) | 4 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Oedema peripheral, 36 months (DCO: Dec 11, 2020) | 4 Participants |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Alopecia, 25 months (DCO: Nov 8, 2019) | 3 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Any TEAE, 36 months (DCO: Dec 11, 2020) | 24 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Oedema peripheral, 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Vomiting, 25 months (DCO: Nov 8, 2019) | 7 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Constipation, 25 months (DCO: Nov 8, 2019) | 5 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Alopecia, 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Nausea, 25 months (DCO: Nov 8, 2019) | 19 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Anaemia, 25 months (DCO: Nov 8, 2019) | 10 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Peripheral sensory neuropathy, 25 months (DCO: Nov 8, 2019) | 0 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Peripheral sensory neuropathy, 36 months (DCO: Dec 11, 2020) | 0 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Platelet count decreased, 36 months (DCO: Dec 11, 2020) | 7 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Lymphocyte count decreased, 25 months (DCO: Nov 8, 2019) | 3 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | White blood cell count decreased, 25 months (DCO: Nov 8, 2019) | 7 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Vomiting, 36 months (DCO: Dec 11, 2020) | 7 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Pyrexia, 36 months (DCO: Dec 11, 2020) | 6 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Dysgeusia, 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | White blood cell count decreased, 36 months (DCO: Dec 11, 2020) | 7 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Lymphocyte count decreased, 36 months (DCO: Dec 11, 2020) | 3 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Neutrophil count decreased, 36 months (DCO: Dec 11, 2020) | 12 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Oedema peripheral, 36 months (DCO: Dec 11, 2020) | 2 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Diarrhoea, 25 months (DCO: Nov 8, 2019) | 8 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Constipation, 36 months (DCO: Dec 11, 2020) | 5 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Anaemia, 36 months (DCO: Dec 11, 2020) | 11 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Weight decreased, 25 months (DCO: Nov 8, 2019) | 7 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Neutrophil count decreased, 25 months (DCO: Nov 8, 2019) | 12 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Malaise, 25 months (DCO: Nov 8, 2019) | 9 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Any TEAE, 25 months (DCO: Nov 8, 2019) | 24 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Platelet count decreased, 25 months (DCO: Nov 8, 2019) | 7 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Dysgeusia, 36 months (DCO: Dec 11, 2020) | 1 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Weight decreased, 36 months (DCO: Dec 11, 2020) | 7 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Decreased appetite, 36 months (DCO: Dec 11, 2020) | 18 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Nausea, 36 months (DCO: Dec 11, 2020) | 19 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Alopecia, 25 months (DCO: Nov 8, 2019) | 1 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Pyrexia, 25 months (DCO: Nov 8, 2019) | 6 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Fatigue, 25 months (DCO: Nov 8, 2019) | 6 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Hypoalbuminaemia, 25 months (DCO: Nov 8, 2019) | 5 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Diarrhoea, 36 months (DCO: Dec 11, 2020) | 8 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Decreased appetite, 25 months (DCO: Nov 8, 2019) | 18 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Malaise, 36 months (DCO: Dec 11, 2020) | 9 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Fatigue, 36 months (DCO: Dec 11, 2020) | 6 Participants |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set) | Hypoalbuminaemia, 36 months (DCO: Dec 11, 2020) | 5 Participants |
Secondary
Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set)
Time to treatment failure (TTF) was defined as the time from the date of randomization (the date of the registration for Exploratory Cohorts) to the earliest date of the first objective documentation of progressive disease (PD), death due to any cause, or treatment discontinuation.
Time frame: From date of randomization to first documentation of PD, death due to any cause, or treatment discontinuation (whichever comes first), up to 36 months postdose
Population: Time to treatment failure (TTF) was assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DS-8201a | Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | TTF, 25 months (DCO: Nov 8, 2019) | 4.2 months |
| DS-8201a | Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | TTF, 36 months (DCO: Dec 11, 2020) | 4.3 months |
| Physician's Choice Irinotecan | Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | TTF, 36 months (DCO: Dec 11, 2020) | 2.6 months |
| Physician's Choice Irinotecan | Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | TTF, 25 months (DCO: Nov 8, 2019) | 2.6 months |
| Physician's Choice Paclitaxel | Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | TTF, 25 months (DCO: Nov 8, 2019) | 2.9 months |
| Physician's Choice Paclitaxel | Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | TTF, 36 months (DCO: Dec 11, 2020) | 2.9 months |
| Physician's Choice Overall | Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | TTF, 25 months (DCO: Nov 8, 2019) | 2.6 months |
| Physician's Choice Overall | Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | TTF, 36 months (DCO: Dec 11, 2020) | 2.6 months |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | TTF, 36 months (DCO: Dec 11, 2020) | 3.7 months |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | TTF, 25 months (DCO: Nov 8, 2019) | 3.7 months |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | TTF, 36 months (DCO: Dec 11, 2020) | 2.2 months |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set) | TTF, 25 months (DCO: Nov 8, 2019) | 2.2 months |