Esophageal Carcinoma, Esophagogastric Junction Carcinoma
Conditions
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Programmed Death-Ligand 2 (PDL2, PD-L2), Gene expression profiling (GEP)
Brief summary
In the China extension study, Chinese participants with advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the esophagogastric junction (EGJ) that has progressed after first-line standard therapy will be randomized to receive either single agent pembrolizumab or the Investigator's choice of chemotherapy with paclitaxel, docetaxel, or irinotecan. The primary extension study hypothesis is that treatment with pembrolizumab will prolong overall survival (OS) as compared to treatment with chemotherapy.
Detailed description
The China extension study will include participants previously enrolled in China in the global study for MK-3475-181 (NCT02564263) plus those enrolled during the China extension enrollment period. Per protocol, response/progression or adverse events during the second pembrolizumab course will not be counted towards efficacy outcome measures or safety outcome measures.
Interventions
BIOLOGICALpembrolizumab
IV infusion
DRUGpaclitaxel
IV infusion
DRUGdocetaxel
IV infusion
DRUGirinotecan
IV infusion
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically- or cytologically-confirmed diagnosis of adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the EGJ * Metastatic disease or locally advanced, unresectable disease * Life expectancy of greater than 3 months * Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 * Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale * Documented radiographic or clinical disease progression on no more or less than one previous line of standard therapy * Can provide either a newly obtained or archival tumor tissue sample for intra-tumoral immune-related testing and for anti-programmed cell death (PD)-1 * Participants of reproductive potential must be willing to use adequate contraception for the course of the study through 120 days after the last dose of pembrolizumab or through 180 days after the last dose of paclitaxel, docetaxel or irinotecan * Adequate organ function
Exclusion criteria
* Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study medication * Active autoimmune disease that has required systemic treatment in past 2 years * Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication * Known central nervous system (CNS) metastases and/or carcinomatous meningitis (includes past history or current metastasis) * Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent * Has had a severe hypersensitivity reaction to treatment with another mAb * Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1), or anti-PD-L2 agent, or previously participated in Merck pembrolizumab (MK-3475) study * Has a known additional malignancy that has progressed or required active treatment within the last 5 years with the exception of curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers, and in-situ or intra-mucosal pharyngeal cancer * Received a live vaccine within 30 days of the first dose of study medication * Known history of Human Immunodeficiency Virus (HIV) infection * Known history of or is positive for hepatitis B (hepatitis B surface antigen reactive) or known active hepatitis C \[hepatitis C virus ribonucleic acid (RNA) or hepatitis C antibody is detected\] * History of non-infectious pneumonitis that required steroids or current pneumonitis * Active infection requiring systemic therapy * Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study * Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study starting with the screening visit through 120 days after the last dose of pembrolizumab or through 180 days after the last dose of paclitaxel, docetaxel or irinotecan * Known allergy, hypersensitivity, or contraindication to paclitaxel, docetaxel, or irinotecan or any components used in their preparation * Experienced weight loss \> 10% over \ 2 months prior to first dose of study therapy * Has ascites or pleural effusion by physical exam * Has experienced documented objective radiographic or clinical disease progression during or after receiving more than 1 line of therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) in All Participants | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | OS was defined as the time from randomization to death due to any cause. Median OS for the first pembrolizumab course in all participants is presented. |
| Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | OS was defined as the time from randomization to death due to any cause. Median OS for the first pembrolizumab course in participants with a PD-L1 CPS ≥10 is presented. |
| Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | OS was defined as the time from randomization to death due to any cause. Median OS for the first pembrolizumab course in participants with SCC of the esophagus is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS for the first pembrolizumab course as assessed by central imaging vendor review per RECIST 1.1 in all participants is presented. |
| Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS for the first pembrolizumab course as assessed by central imaging vendor review per RECIST 1.1 is presented for participants with a PD-L1 CPS ≥10. |
| Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1 by central imaging vendor review. The percentage of all participants who experienced a CR or PR for the first pembrolizumab course is presented. |
| Number of Participants Experiencing an Adverse Event (AE) | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced ≥1 AE for the first pembrolizumab course are presented. |
| Number of Participants Discontinuing Study Treatment Due an Adverse Event (AE) | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE for the first pembrolizumab course are presented. |
| Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS for the first pembrolizumab course as assessed by central imaging vendor review per RECIST 1.1 is presented for participants with SCC of the esophagus. |
| Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1 by central imaging vendor review. The percentage of participants with a PD-L1 CPS ≥10 who experienced a CR or PR for the first pembrolizumab course is presented. |
| Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1 by central imaging vendor review. The percentage of participants with SCC of the esophagus who experienced a CR or PR for the first pembrolizumab course is presented. |
Countries
China
Participant flow
Pre-assignment details
Per protocol, response/progression or adverse events during the second pembrolizumab course were not counted towards efficacy outcome measures or safety outcome measures. Final analysis of all outcome measures was done at the protocol-specified analysis cutoff of 13-Feb-2019.
Participants by arm
| Arm | Count |
|---|---|
| Pembrolizumab Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 21-day (3 week) cycle for up to 35 administrations (up to \
2 years). Participants who completed the first course of up to 35 administrations of pembrolizumab (\
2 years) but progressed after discontinuation, were eligible for a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \
1 year). | 62 |
| Chemotherapy Participants received Investigator's choice of chemotherapy for up to \
2 years: paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle. | 61 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 4 |
| Overall Study | Death | 55 | 57 |
| Overall Study | Sponsor Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Pembrolizumab | Chemotherapy | Total |
|---|---|---|---|
| Age, Continuous | 60.1 Years STANDARD_DEVIATION 7 | 59.6 Years STANDARD_DEVIATION 7 | 59.9 Years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants | 61 Participants | 123 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Programmed Death-Ligand 1 (PD-L1) Status: Combined Positive Score (CPS) Not Evaluable | 2 Participants | 1 Participants | 3 Participants |
| Programmed Death-Ligand 1 (PD-L1) Status: Combined Positive Score (CPS) PD-L1 CPS <10 | 35 Participants | 31 Participants | 66 Participants |
| Programmed Death-Ligand 1 (PD-L1) Status: Combined Positive Score (CPS) PD-L1 CPS ≥10 | 25 Participants | 29 Participants | 54 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 62 Participants | 61 Participants | 123 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 57 Participants | 58 Participants | 115 Participants |
| Tumor Histology Adenocarcinoma of esophagus & EGJ Siewert type I | 2 Participants | 2 Participants | 4 Participants |
| Tumor Histology Squamous cell carcinoma | 60 Participants | 59 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 61 / 62 | 61 / 61 | 0 / 1 |
| other Total, other adverse events | 58 / 62 | 55 / 59 | 1 / 1 |
| serious Total, serious adverse events | 23 / 62 | 23 / 59 | 0 / 1 |
Outcome results
Primary
Overall Survival (OS) in All Participants
OS was defined as the time from randomization to death due to any cause. Median OS for the first pembrolizumab course in all participants is presented.
Time frame: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Population: The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pembrolizumab | Overall Survival (OS) in All Participants | 8.4 Months |
| Chemotherapy | Overall Survival (OS) in All Participants | 5.6 Months |
p-value: 0.001595% CI: [0.36, 0.82]Log Rank
Primary
Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)
OS was defined as the time from randomization to death due to any cause. Median OS for the first pembrolizumab course in participants with a PD-L1 CPS ≥10 is presented.
Time frame: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Population: The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pembrolizumab | Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | 12.0 Months |
| Chemotherapy | Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | 5.3 Months |
p-value: 0.000895% CI: [0.17, 0.69]Log Rank
Primary
Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus
OS was defined as the time from randomization to death due to any cause. Median OS for the first pembrolizumab course in participants with SCC of the esophagus is presented.
Time frame: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Population: The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pembrolizumab | Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | 8.4 Months |
| Chemotherapy | Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | 5.6 Months |
p-value: 0.002195% CI: [0.37, 0.83]Log Rank
Secondary
Number of Participants Discontinuing Study Treatment Due an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE for the first pembrolizumab course are presented.
Time frame: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Population: All randomized participants who received at least one dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pembrolizumab | Number of Participants Discontinuing Study Treatment Due an Adverse Event (AE) | 10 Participants |
| Chemotherapy | Number of Participants Discontinuing Study Treatment Due an Adverse Event (AE) | 9 Participants |
Secondary
Number of Participants Experiencing an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced ≥1 AE for the first pembrolizumab course are presented.
Time frame: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Population: All randomized participants who received at least one dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pembrolizumab | Number of Participants Experiencing an Adverse Event (AE) | 62 Participants |
| Chemotherapy | Number of Participants Experiencing an Adverse Event (AE) | 56 Participants |
Secondary
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1 by central imaging vendor review. The percentage of all participants who experienced a CR or PR for the first pembrolizumab course is presented.
Time frame: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Population: The efficacy analysis population consisted of all randomized participants who experienced a confirmed response (CR or PR). Participants were included in the treatment group to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pembrolizumab | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | 16.1 Percentage of Participants |
| Chemotherapy | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | 3.3 Percentage of Participants |
p-value: 0.008495% CI: [2.7, 24.5]Miettinen & Nurminen method
Secondary
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1 by central imaging vendor review. The percentage of participants with a PD-L1 CPS ≥10 who experienced a CR or PR for the first pembrolizumab course is presented.
Time frame: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Population: The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10 who experienced a confirmed response (CR or PR). Participants were included in the treatment group to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pembrolizumab | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | 24.0 Percentage of Participants |
| Chemotherapy | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | 6.9 Percentage of Participants |
p-value: 0.040395% CI: [-2.3, 38]Miettinen & Nurminen method
Secondary
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1 by central imaging vendor review. The percentage of participants with SCC of the esophagus who experienced a CR or PR for the first pembrolizumab course is presented.
Time frame: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Population: The efficacy analysis population consisted of all randomized participants with SCC of the esophagus who experienced a confirmed response (CR or PR). Participants were included in the treatment group to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pembrolizumab | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | 16.7 Percentage of Participants |
| Chemotherapy | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | 3.4 Percentage of Participants |
p-value: 0.008395% CI: [2.8, 25.2]Miettinen & Nurminen method
Secondary
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS for the first pembrolizumab course as assessed by central imaging vendor review per RECIST 1.1 in all participants is presented.
Time frame: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Population: The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pembrolizumab | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | 2.5 Months |
| Chemotherapy | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | 2.8 Months |
p-value: 0.17795% CI: [0.58, 1.23]Log Rank
Secondary
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS for the first pembrolizumab course as assessed by central imaging vendor review per RECIST 1.1 is presented for participants with a PD-L1 CPS ≥10.
Time frame: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Population: The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pembrolizumab | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | 4.0 Months |
| Chemotherapy | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | 4.0 Months |
p-value: 0.23895% CI: [0.44, 1.46]Log Rank
Secondary
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS for the first pembrolizumab course as assessed by central imaging vendor review per RECIST 1.1 is presented for participants with SCC of the esophagus.
Time frame: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Population: The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pembrolizumab | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | 2.3 Months |
| Chemotherapy | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | 2.8 Months |
p-value: 0.17195% CI: [0.57, 1.23]Log Rank