Esophageal Squamous Cell Carcinoma (ESCC)
Conditions
Keywords
Unresectable, metastatic, second-line, squamous, esophagus, chemotherapy, paclitaxel, docetaxel, irinotecan
Brief summary
The purpose of this study was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that had progressed during or after first line therapy.
Interventions
DRUGTislelizumab
200 mg administered intravenously (IV)
DRUGPaclitaxel
135-175 mg /m² administered IV , or 80-100 mg/m\^2 administered IV according to local guidelines for standard of care
DRUGDocetaxel
75 mg/m\^2 administered IV or 70 mg/m\^2 IV in Japan
DRUGIrinotecan
125 mg/m\^2 administered IV
Sponsors
BeiGene
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
Key Inclusion Criteria: 1. Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC) 2. Tumor progression during or after first-line treatment for advanced unresectable / metastatic ESCC 3. At least one measurable/evaluable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to randomization Key
Exclusion criteria
1. Receipt of 2 or more prior systemic treatments for advanced/metastatic unresectable ESCC 2. History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to randomization 3. Tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula in the study treatment assessed by investigator 4. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage 5. Received prior therapies targeting programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1) 6. Prior malignancy active within the previous 2 years (exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast) 7. Active brain or leptomeningeal metastasis. 8. Has active autoimmune disease or history of autoimmune diseases at high risk for relapse 9. Known history of, or any evidence of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis diagnosed based on imaging or clinical findings, or uncontrolled systemic diseases, including diabetes, hypertension, acute lung diseases, etc 10. Known history of Human Immunodeficiency Virus (HIV) 11. Has cardiovascular risk factors 12. Pregnant or breastfeeding woman. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set | Approximately 2 years and 10 months from date of first randomization | OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) in the ITT Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; |
| Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1; |
| Progression-free Survival (PFS) in the ITT Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the ITT analysis set |
| Progression-free Survival (PFS) in the PDL-1 Positive Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the PDL-1 Positive Analysis Set |
| Duration of Response (DOR) in the ITT Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first |
| Duration of Response (DOR) in the PDL-1 Positive Analysis Set. | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first |
| Overall Survival (OS) in the PDL-1 Positive Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | OS is defined as the time from the date of randomization until the date of death due to any cause in the PD-L1 positive population, defined as vCPS ≥10%. |
| HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set | Baseline to Cycle 6 (21 days per cycle) | Mean change from baseline in EORTC QLQ-C30 Index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes |
| HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set | Baseline to Cycle 6 (21 days per cycle) | Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes. |
| HRQoL as Assessed by EORTC QLQ-OES18) in the PDL-1 Positive Analysis Set. | Baseline to Cycle 6 (21 days per cycle) | Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes. |
| HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) in the ITT Analysis Set | Baseline to Cycle 6 (21 days per cycle) | Mean change from baseline in EQ-5D-5L visual acuity score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes. |
| HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set | Baseline to Cycle 6 (21 days per cycle) | Mean change from baseline in EQ-5D-5L visual acuity score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes. |
| Number of Participants Experiencing Adverse Events (AEs) | From the first dose date to 30 days after the last dose date; up to approximately 4 years and 11 months | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs |
| Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set | Baseline to Cycle 6 (21 days per cycle) | Mean change from baseline in EORTC QLQ-C30 index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes |
Countries
Belgium, China, France, Germany, Italy, Japan, South Korea, Spain, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
This study was conducted at 132 study centers in Mainland China, Taiwan, United States, France, Italy, Germany, Spain, Japan, South Korea, Belgium and the United Kingdom.
Participants by arm
| Arm | Count |
|---|---|
| Tislelizumab Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met. | 256 |
| Investigator Chosen Chemotherapy Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days | 256 |
| Total | 512 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 233 | 233 |
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Sponsor Decision | 17 | 6 |
| Overall Study | Withdrawal by Subject | 5 | 14 |
Baseline characteristics
| Characteristic | Tislelizumab | Investigator Chosen Chemotherapy | Total |
|---|---|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 8.41 | 61.8 years STANDARD_DEVIATION 8.02 | 61.8 years STANDARD_DEVIATION 8.21 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 | 66 Participants | 61 Participants | 127 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Score 1 | 190 Participants | 195 Participants | 385 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 252 Participants | 252 Participants | 504 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| PD-L1 Expression Status Missing | 76 Participants | 72 Participants | 148 Participants |
| PD-L1 Expression Status vCPS < 10% | 100 Participants | 122 Participants | 222 Participants |
| PD-L1 Expression Status vCPS >= 10% | 80 Participants | 62 Participants | 142 Participants |
| Race/Ethnicity, Customized Race Asian | 201 Participants | 207 Participants | 408 Participants |
| Race/Ethnicity, Customized Race Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Unknown | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Race White or Caucasian | 53 Participants | 44 Participants | 97 Participants |
| Sex: Female, Male Female | 39 Participants | 41 Participants | 80 Participants |
| Sex: Female, Male Male | 217 Participants | 215 Participants | 432 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 233 / 256 | 233 / 256 |
| other Total, other adverse events | 232 / 255 | 231 / 240 |
| serious Total, serious adverse events | 109 / 255 | 106 / 240 |
Outcome results
Primary
Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set
OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants
Time frame: Approximately 2 years and 10 months from date of first randomization
Population: The ITT analysis set included all randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tislelizumab | Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set | 8.6 Months |
| Investigator Chosen Chemotherapy | Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set | 6.3 Months |
p-value: 0.000195% CI: [0.57, 0.85]1-sided, Log Rank Test
Secondary
Duration of Response (DOR) in the ITT Analysis Set
DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first
Time frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Population: The ITT analysis set included all randomized participants; only participants with an objective response (CR or PR) were included in this analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tislelizumab | Duration of Response (DOR) in the ITT Analysis Set | 7.1 Months |
| Investigator Chosen Chemotherapy | Duration of Response (DOR) in the ITT Analysis Set | 4.0 Months |
Secondary
Duration of Response (DOR) in the PDL-1 Positive Analysis Set.
DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first
Time frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Population: The PD-L1 positive population is defined as a visually estimated combined positive score (vCPS) ≥10%; only participants with an objective response (CR or PR) were included in this analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tislelizumab | Duration of Response (DOR) in the PDL-1 Positive Analysis Set. | 7.1 Months |
| Investigator Chosen Chemotherapy | Duration of Response (DOR) in the PDL-1 Positive Analysis Set. | 5.7 Months |
Secondary
Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set
Mean change from baseline in EORTC QLQ-C30 index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes
Time frame: Baseline to Cycle 6 (21 days per cycle)
Population: The ITT analysis set included all randomized participants; Overall number of participants analyzed refers to number of participants evaluable for this outcome measure and Number analyzed refers to participants evaluable at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tislelizumab | Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set | Baseline | 16.2 Score on a scale | Standard Deviation 12.28 |
| Tislelizumab | Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set | Change at Cycle 6 | 0.2 Score on a scale | Standard Deviation 8.28 |
| Investigator Chosen Chemotherapy | Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set | Baseline | 18.3 Score on a scale | Standard Deviation 13.86 |
| Investigator Chosen Chemotherapy | Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set | Change at Cycle 6 | 4.8 Score on a scale | Standard Deviation 9.38 |
Secondary
HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set
Mean change from baseline in EORTC QLQ-C30 Index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes
Time frame: Baseline to Cycle 6 (21 days per cycle)
Population: The PD-L1 positive population is defined as a visually estimated combined positive score (vCPS) ≥10%; Overall number of participants analyzed refers to number of participants evaluable for this outcome measure and Number analyzed refers to participants evaluable at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tislelizumab | HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set | Baseline | 16.8 Score on a scale | Standard Deviation 10.96 |
| Tislelizumab | HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set | Change at Cycle 6 | 0.5 Score on a scale | Standard Deviation 7.39 |
| Investigator Chosen Chemotherapy | HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set | Baseline | 18.8 Score on a scale | Standard Deviation 12.02 |
| Investigator Chosen Chemotherapy | HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set | Change at Cycle 6 | 0.5 Score on a scale | Standard Deviation 4.86 |
Secondary
HRQoL as Assessed by EORTC QLQ-OES18) in the PDL-1 Positive Analysis Set.
Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.
Time frame: Baseline to Cycle 6 (21 days per cycle)
Population: The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%; Overall number of participants analyzed refers to number of participants evaluable for this outcome measure and Number analyzed refers to participants evaluable at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tislelizumab | HRQoL as Assessed by EORTC QLQ-OES18) in the PDL-1 Positive Analysis Set. | Change at Cycle 6 | -0.9 Score on a scale | Standard Deviation 7.45 |
| Tislelizumab | HRQoL as Assessed by EORTC QLQ-OES18) in the PDL-1 Positive Analysis Set. | Baseline | 16.5 Score on a scale | Standard Deviation 12.69 |
| Investigator Chosen Chemotherapy | HRQoL as Assessed by EORTC QLQ-OES18) in the PDL-1 Positive Analysis Set. | Baseline | 18.1 Score on a scale | Standard Deviation 12.21 |
| Investigator Chosen Chemotherapy | HRQoL as Assessed by EORTC QLQ-OES18) in the PDL-1 Positive Analysis Set. | Change at Cycle 6 | -2.9 Score on a scale | Standard Deviation 5.16 |
Secondary
HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set
Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.
Time frame: Baseline to Cycle 6 (21 days per cycle)
Population: The ITT analysis set included all randomized participants; Overall number of participants analyzed refers to number of participants evaluable for this outcome measure and Number analyzed refers to participants evaluable at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tislelizumab | HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set | Baseline | 14.7 Score on a scale | Standard Deviation 11.81 |
| Tislelizumab | HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set | Change at Cycle 6 | -0.6 Score on a scale | Standard Deviation 8.63 |
| Investigator Chosen Chemotherapy | HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set | Baseline | 16.3 Score on a scale | Standard Deviation 13.2 |
| Investigator Chosen Chemotherapy | HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set | Change at Cycle 6 | 3.0 Score on a scale | Standard Deviation 12.05 |
Secondary
HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set
Mean change from baseline in EQ-5D-5L visual acuity score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.
Time frame: Baseline to Cycle 6 (21 days per cycle)
Population: The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%; Overall number of participants analyzed refers to number of participants evaluable for this outcome measure and Number analyzed refers to participants evaluable at the specified time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tislelizumab | HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set | Baseline | 74.1 Score on a scale | Standard Deviation 14.84 |
| Tislelizumab | HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set | Change at Cycle 6 | -0.5 Score on a scale | Standard Deviation 17.59 |
| Investigator Chosen Chemotherapy | HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set | Baseline | 70.5 Score on a scale | Standard Deviation 18.4 |
| Investigator Chosen Chemotherapy | HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set | Change at Cycle 6 | 4.4 Score on a scale | Standard Deviation 12.82 |
Secondary
HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) in the ITT Analysis Set
Mean change from baseline in EQ-5D-5L visual acuity score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.
Time frame: Baseline to Cycle 6 (21 days per cycle)
Population: The ITT analysis set included all randomized participants; Overall number of participants analyzed refers to number of participants evaluable for this outcome measure and Number analyzed refers to participants evaluable at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tislelizumab | HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) in the ITT Analysis Set | Change at Cycle 6 | -0.6 Score on a scale | Standard Deviation 14.81 |
| Tislelizumab | HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) in the ITT Analysis Set | Baseline | 73.7 Score on a scale | Standard Deviation 17.05 |
| Investigator Chosen Chemotherapy | HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) in the ITT Analysis Set | Change at Cycle 6 | -5.9 Score on a scale | Standard Deviation 16.34 |
| Investigator Chosen Chemotherapy | HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) in the ITT Analysis Set | Baseline | 72.5 Score on a scale | Standard Deviation 18.13 |
Secondary
Number of Participants Experiencing Adverse Events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs
Time frame: From the first dose date to 30 days after the last dose date; up to approximately 4 years and 11 months
Population: Safety analysis set included all participants who received ≥ 1 dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tislelizumab | Number of Participants Experiencing Adverse Events (AEs) | Number of participants with TEAEs | 245 Participants |
| Tislelizumab | Number of Participants Experiencing Adverse Events (AEs) | Number of participants with SAEs | 109 Participants |
| Investigator Chosen Chemotherapy | Number of Participants Experiencing Adverse Events (AEs) | Number of participants with TEAEs | 236 Participants |
| Investigator Chosen Chemotherapy | Number of Participants Experiencing Adverse Events (AEs) | Number of participants with SAEs | 106 Participants |
Secondary
Objective Response Rate (ORR) in the ITT Analysis Set
ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
Time frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Population: The ITT analysis set included all randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tislelizumab | Objective Response Rate (ORR) in the ITT Analysis Set | 20.3 Percentage of Participants |
| Investigator Chosen Chemotherapy | Objective Response Rate (ORR) in the ITT Analysis Set | 9.8 Percentage of Participants |
Secondary
Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets
ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1;
Time frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Population: The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tislelizumab | Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets | 26.3 Percentage of Participants |
| Investigator Chosen Chemotherapy | Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets | 11.3 Percentage of Participants |
Secondary
Overall Survival (OS) in the PDL-1 Positive Analysis Set
OS is defined as the time from the date of randomization until the date of death due to any cause in the PD-L1 positive population, defined as vCPS ≥10%.
Time frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Population: The PD-L1 positive population included all randomized participants with tumor PD-L1 vCPS ≥10%
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tislelizumab | Overall Survival (OS) in the PDL-1 Positive Analysis Set | 10.2 Months |
| Investigator Chosen Chemotherapy | Overall Survival (OS) in the PDL-1 Positive Analysis Set | 5.1 Months |
Secondary
Progression-free Survival (PFS) in the ITT Analysis Set
PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the ITT analysis set
Time frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Population: The ITT analysis set included all randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tislelizumab | Progression-free Survival (PFS) in the ITT Analysis Set | 1.6 Months |
| Investigator Chosen Chemotherapy | Progression-free Survival (PFS) in the ITT Analysis Set | 2.1 Months |
Secondary
Progression-free Survival (PFS) in the PDL-1 Positive Analysis Set
PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the PDL-1 Positive Analysis Set
Time frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Population: The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tislelizumab | Progression-free Survival (PFS) in the PDL-1 Positive Analysis Set | 2.7 Months |
| Investigator Chosen Chemotherapy | Progression-free Survival (PFS) in the PDL-1 Positive Analysis Set | 2.3 Months |