Limited Stage Small Cell Lung Cancer
Conditions
Brief summary
This phase 2 trial examined whether the preliminary efficacy and safety of ociperlimab, tislelizumab, and cCRT when used in combination is expected to advance treatment options in the serious unmet medical need population of Limited-Stage Small Cell Lung Cancer (LS-SCLC) participants .
Interventions
DRUGOciperlimab
Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
DRUGTislelizumab
Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
DRUGConcurrent Chemoradiotherapy
Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
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: * Participant has pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer * Has limited-stage disease (stage Tx, T1-T4, N0-3, M0; AJCC staging, 8th edition), and can be safely treated with definitive radiation doses. * Participant has not received any prior treatment for LS-SCLC. * Participant has measurable disease as assessed according to RECIST v1.1 that is appropriate for selection as a target lesion for repeat measurement, as determined by local site investigator/radiology review * ECOG Performance Status ≤ 2 assessed within 7 days before the first administration of study intervention, and must have a life expectancy of ≥ 12 weeks. Key
Exclusion criteria
* Mixed small cell lung cancer histology. Note: mixed SCLC with the component of neuroendocrine carcinoma origin is considered eligible * Have received surgical resection for LS-SCLC * Any participant for whom the tumor is considered resectable by surgery or stereotactic body radiation therapy/stereotactic ablative radiotherapy should be considered ineligible * Is expected to require any other form of antineoplastic therapy while on study. * Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways Note: Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Up to approximately 2 years | Defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Up to approximately 2 years | defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1 |
| Overall Response Rate (ORR) in the Programmed Death-Ligand 1 (PD-L1) Analysis Set | Up to approximately 2 years | defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1 |
| Overall Response Rate (ORR) in the T Cell Immunoreceptor With Immunoglobulin and ITIM Domain (TIGIT) Analysis Set | Up to approximately 2 years | defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1 |
| Duration of Response (DOR) | Up to approximately 2 years | defined as the time from the date of the first occurrence of a documented objective response to the date of documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first) |
| Overall Survival (OS) in the ITT Analysis Set | Up to approximately 2 years | Defined as the time from the date of randomization to the date of death due to any cause |
| Complete Response Rate (CR) | Up to approximately 2 years | defined as the percentage of participants who had CR as assessed by the investigator per RECIST v1.1 |
| Overall Survival (OS) in the TIGIT Analysis Set | Up to approximately 2 years | defined as the time from the date of randomization to the date of death due to any cause |
| Distant Metastasis-free Survival (DMFS) | Up to approximately 2 years | defined as the time from the date of randomization to the date of the first documented distant metastasis as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first) |
| PFS in the PD-L1 Analysis Set | Up to approximately 2 years | defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first), |
| PFS in the TIGIT Analysis Set | Up to approximately 2 years | defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first), |
| Number of Participants Experiencing Adverse Events (AEs) | From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.03 |
| Overall Survival (OS) in the PD-L1 Analysis Set | Up to approximately 2 years | defined as the time from the date of randomization to the date of death due to any cause |
Countries
China, South Korea, United States
Participant flow
Recruitment details
Participants were enrolled in multiple study centers in China, South Korea, and the United States.
Participants by arm
| Arm | Count |
|---|---|
| Arm A: Ociperlimab + Tislelizumab Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
Ociperlimab: Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) | 41 |
| Arm B: Tislelizumab Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) | 42 |
| Arm C: Concurrent Chemoradiotherapy (cCRT) cCRT only for 4 cycles at the investigator's discretion
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy) | 43 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 12 | 13 | 14 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 3 |
Baseline characteristics
| Characteristic | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) | Total |
|---|---|---|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 9.5 | 59.9 years STANDARD_DEVIATION 7.11 | 61.0 years STANDARD_DEVIATION 9.54 | 60.5 years STANDARD_DEVIATION 8.73 |
| Race/Ethnicity, Customized Asian | 41 Participants | 42 Participants | 42 Participants | 125 Participants |
| Race/Ethnicity, Customized White | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 8 Participants | 27 Participants |
| Sex: Female, Male Male | 31 Participants | 33 Participants | 35 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 12 / 41 | 13 / 42 | 14 / 43 |
| other Total, other adverse events | 41 / 41 | 42 / 42 | 43 / 43 |
| serious Total, serious adverse events | 25 / 41 | 20 / 42 | 12 / 43 |
Outcome results
Primary
Progression Free Survival (PFS)
Defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)
Time frame: Up to approximately 2 years
Population: The ITT analysis set includes all randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Ociperlimab + Tislelizumab | Progression Free Survival (PFS) | 12.6 Months |
| Arm B: Tislelizumab | Progression Free Survival (PFS) | 13.2 Months |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | Progression Free Survival (PFS) | 9.5 Months |
Secondary
Complete Response Rate (CR)
defined as the percentage of participants who had CR as assessed by the investigator per RECIST v1.1
Time frame: Up to approximately 2 years
Population: The Intent-To-Treat (ITT) analysis set includes all randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Ociperlimab + Tislelizumab | Complete Response Rate (CR) | 7.3 percentage of participants |
| Arm B: Tislelizumab | Complete Response Rate (CR) | 9.5 percentage of participants |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | Complete Response Rate (CR) | 2.3 percentage of participants |
Secondary
Distant Metastasis-free Survival (DMFS)
defined as the time from the date of randomization to the date of the first documented distant metastasis as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)
Time frame: Up to approximately 2 years
Population: The Intent-To-Treat (ITT) analysis set includes all randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Ociperlimab + Tislelizumab | Distant Metastasis-free Survival (DMFS) | 17.9 months |
| Arm B: Tislelizumab | Distant Metastasis-free Survival (DMFS) | 15.3 months |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | Distant Metastasis-free Survival (DMFS) | 20.0 months |
Secondary
Duration of Response (DOR)
defined as the time from the date of the first occurrence of a documented objective response to the date of documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)
Time frame: Up to approximately 2 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) |
|---|---|---|
| Arm A: Ociperlimab + Tislelizumab | Duration of Response (DOR) | 10.1 Months |
| Arm B: Tislelizumab | Duration of Response (DOR) | 11.5 Months |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | Duration of Response (DOR) | 8.2 Months |
Secondary
Number of Participants Experiencing Adverse Events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.03
Time frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
Population: The Safety Analysis Set includes all patients who have received \>= 1 dose of any component of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Ociperlimab + Tislelizumab | Number of Participants Experiencing Adverse Events (AEs) | Number of Participants with at least one TEAE | 41 Participants |
| Arm A: Ociperlimab + Tislelizumab | Number of Participants Experiencing Adverse Events (AEs) | Number of participants with at least one SAE | 25 Participants |
| Arm B: Tislelizumab | Number of Participants Experiencing Adverse Events (AEs) | Number of Participants with at least one TEAE | 42 Participants |
| Arm B: Tislelizumab | Number of Participants Experiencing Adverse Events (AEs) | Number of participants with at least one SAE | 20 Participants |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | Number of Participants Experiencing Adverse Events (AEs) | Number of Participants with at least one TEAE | 43 Participants |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | Number of Participants Experiencing Adverse Events (AEs) | Number of participants with at least one SAE | 12 Participants |
Secondary
Overall Response Rate (ORR)
defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1
Time frame: Up to approximately 2 years
Population: The Intent-To-Treat (ITT) analysis set includes all randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Ociperlimab + Tislelizumab | Overall Response Rate (ORR) | 85.4 percentage of participants |
| Arm B: Tislelizumab | Overall Response Rate (ORR) | 88.1 percentage of participants |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | Overall Response Rate (ORR) | 76.7 percentage of participants |
Secondary
Overall Response Rate (ORR) in the Programmed Death-Ligand 1 (PD-L1) Analysis Set
defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1
Time frame: Up to approximately 2 years
Population: The PD-L1 Analysis Set includes all patients who have at least 1 evaluable PD-L1 measurement expressed by Tumor Area Percentage (TAP).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Ociperlimab + Tislelizumab | Overall Response Rate (ORR) in the Programmed Death-Ligand 1 (PD-L1) Analysis Set | PD-L1 Expression in TAP ( >=1%) | 85.7 percentage of participants |
| Arm A: Ociperlimab + Tislelizumab | Overall Response Rate (ORR) in the Programmed Death-Ligand 1 (PD-L1) Analysis Set | PD-L1 Expression in TAP (<1%) | 93.8 percentage of participants |
| Arm B: Tislelizumab | Overall Response Rate (ORR) in the Programmed Death-Ligand 1 (PD-L1) Analysis Set | PD-L1 Expression in TAP ( >=1%) | 94.1 percentage of participants |
| Arm B: Tislelizumab | Overall Response Rate (ORR) in the Programmed Death-Ligand 1 (PD-L1) Analysis Set | PD-L1 Expression in TAP (<1%) | 81.8 percentage of participants |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | Overall Response Rate (ORR) in the Programmed Death-Ligand 1 (PD-L1) Analysis Set | PD-L1 Expression in TAP ( >=1%) | 76.5 percentage of participants |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | Overall Response Rate (ORR) in the Programmed Death-Ligand 1 (PD-L1) Analysis Set | PD-L1 Expression in TAP (<1%) | 86.7 percentage of participants |
Secondary
Overall Response Rate (ORR) in the T Cell Immunoreceptor With Immunoglobulin and ITIM Domain (TIGIT) Analysis Set
defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1
Time frame: Up to approximately 2 years
Population: The TIGIT Analysis Set includes all patients who have at least 1 evaluable TIGIT measurement expressed by Immune Cells (IC) percentage.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Ociperlimab + Tislelizumab | Overall Response Rate (ORR) in the T Cell Immunoreceptor With Immunoglobulin and ITIM Domain (TIGIT) Analysis Set | TIGIT Expression Level in IC (>=1%) | 88.9 percentage of participants |
| Arm A: Ociperlimab + Tislelizumab | Overall Response Rate (ORR) in the T Cell Immunoreceptor With Immunoglobulin and ITIM Domain (TIGIT) Analysis Set | TIGIT Expression Level in IC (<1%) | 86.7 percentage of participants |
| Arm B: Tislelizumab | Overall Response Rate (ORR) in the T Cell Immunoreceptor With Immunoglobulin and ITIM Domain (TIGIT) Analysis Set | TIGIT Expression Level in IC (>=1%) | 88.0 percentage of participants |
| Arm B: Tislelizumab | Overall Response Rate (ORR) in the T Cell Immunoreceptor With Immunoglobulin and ITIM Domain (TIGIT) Analysis Set | TIGIT Expression Level in IC (<1%) | 100.0 percentage of participants |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | Overall Response Rate (ORR) in the T Cell Immunoreceptor With Immunoglobulin and ITIM Domain (TIGIT) Analysis Set | TIGIT Expression Level in IC (>=1%) | 93.8 percentage of participants |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | Overall Response Rate (ORR) in the T Cell Immunoreceptor With Immunoglobulin and ITIM Domain (TIGIT) Analysis Set | TIGIT Expression Level in IC (<1%) | 68.4 percentage of participants |
Secondary
Overall Survival (OS) in the ITT Analysis Set
Defined as the time from the date of randomization to the date of death due to any cause
Time frame: Up to approximately 2 years
Population: The Intent-To-Treat (ITT) analysis set includes all randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Ociperlimab + Tislelizumab | Overall Survival (OS) in the ITT Analysis Set | NA months |
| Arm B: Tislelizumab | Overall Survival (OS) in the ITT Analysis Set | NA months |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | Overall Survival (OS) in the ITT Analysis Set | NA months |
Secondary
Overall Survival (OS) in the PD-L1 Analysis Set
defined as the time from the date of randomization to the date of death due to any cause
Time frame: Up to approximately 2 years
Population: The PD-L1 Analysis Set includes all patients who have at least 1 evaluable PD-L1 measurement expressed by Tumor Area Percentage (TAP).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: Ociperlimab + Tislelizumab | Overall Survival (OS) in the PD-L1 Analysis Set | PD-L1 Expression in TAP (>=1%) | NA months |
| Arm A: Ociperlimab + Tislelizumab | Overall Survival (OS) in the PD-L1 Analysis Set | PD-L1 Expression in TAP (<1%) | NA months |
| Arm B: Tislelizumab | Overall Survival (OS) in the PD-L1 Analysis Set | PD-L1 Expression in TAP (>=1%) | NA months |
| Arm B: Tislelizumab | Overall Survival (OS) in the PD-L1 Analysis Set | PD-L1 Expression in TAP (<1%) | NA months |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | Overall Survival (OS) in the PD-L1 Analysis Set | PD-L1 Expression in TAP (>=1%) | NA months |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | Overall Survival (OS) in the PD-L1 Analysis Set | PD-L1 Expression in TAP (<1%) | NA months |
Secondary
Overall Survival (OS) in the TIGIT Analysis Set
defined as the time from the date of randomization to the date of death due to any cause
Time frame: Up to approximately 2 years
Population: The TIGIT Analysis Set includes all patients who have at least 1 evaluable TIGIT measurement expressed by immune cells percentage.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: Ociperlimab + Tislelizumab | Overall Survival (OS) in the TIGIT Analysis Set | TIGIT Expression Level in IC (>=1%) | NA months |
| Arm A: Ociperlimab + Tislelizumab | Overall Survival (OS) in the TIGIT Analysis Set | TIGIT Expression Level in IC (<1%) | NA months |
| Arm B: Tislelizumab | Overall Survival (OS) in the TIGIT Analysis Set | TIGIT Expression Level in IC (>=1%) | NA months |
| Arm B: Tislelizumab | Overall Survival (OS) in the TIGIT Analysis Set | TIGIT Expression Level in IC (<1%) | NA months |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | Overall Survival (OS) in the TIGIT Analysis Set | TIGIT Expression Level in IC (>=1%) | NA months |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | Overall Survival (OS) in the TIGIT Analysis Set | TIGIT Expression Level in IC (<1%) | NA months |
Secondary
PFS in the PD-L1 Analysis Set
defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first),
Time frame: Up to approximately 2 years
Population: The PD-L1 Analysis Set includes all patients who have at least 1 evaluable PD-L1 measurement expressed by Tumor Area Percentage (TAP).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: Ociperlimab + Tislelizumab | PFS in the PD-L1 Analysis Set | PD-L1 Expression in TAP ( >=1%) | 12.6 months |
| Arm A: Ociperlimab + Tislelizumab | PFS in the PD-L1 Analysis Set | PD-L1 Expression in TAP (<1%) | 10.3 months |
| Arm B: Tislelizumab | PFS in the PD-L1 Analysis Set | PD-L1 Expression in TAP ( >=1%) | 15.0 months |
| Arm B: Tislelizumab | PFS in the PD-L1 Analysis Set | PD-L1 Expression in TAP (<1%) | 14.8 months |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | PFS in the PD-L1 Analysis Set | PD-L1 Expression in TAP ( >=1%) | 11.1 months |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | PFS in the PD-L1 Analysis Set | PD-L1 Expression in TAP (<1%) | 14.4 months |
Secondary
PFS in the TIGIT Analysis Set
defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first),
Time frame: Up to approximately 2 years
Population: The TIGIT Analysis Set includes all patients who have at least 1 evaluable TIGIT measurement expressed by immune cells percentage.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: Ociperlimab + Tislelizumab | PFS in the TIGIT Analysis Set | TIGIT Expression Level in IC (>=1%) | 17.9 months |
| Arm A: Ociperlimab + Tislelizumab | PFS in the TIGIT Analysis Set | TIGIT Expression Level in IC (<1%) | 8.7 months |
| Arm B: Tislelizumab | PFS in the TIGIT Analysis Set | TIGIT Expression Level in IC (>=1%) | 14.3 months |
| Arm B: Tislelizumab | PFS in the TIGIT Analysis Set | TIGIT Expression Level in IC (<1%) | NA months |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | PFS in the TIGIT Analysis Set | TIGIT Expression Level in IC (>=1%) | 11.2 months |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | PFS in the TIGIT Analysis Set | TIGIT Expression Level in IC (<1%) | 14.4 months |