Phase 3
N=997
Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma
Gastric, or Gastroesophageal Junction Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03777657 ↗Enrolled (actual)
997
Serious AEs
39.3%
Results posted
Feb 2025
Primary outcome: Primary: Overall Survival in PD-L1 Positive Participants — 17.2; 12.6 months — p=0.0056
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tislelizumab (Drug); Placebo (Drug); Cisplatin (Drug); Oxaliplatin (Drug); Capecitabine (Drug); 5-Fluorouracil (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BeiGene
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival in PD-L1 Positive Participants |
17.2; 12.6 | 0.0056 sig |
| PRIMARY Overall Survival in the Intent-to-Treat (ITT) Analysis Set |
15.0; 12.9 | 0.0011 sig |
| SECONDARY Progression-free Survival (PFS) in PD-L1 Positive Participants |
7.2; 5.9 | — |
| SECONDARY Overall Response Rate (ORR) in PD-L1 Positive Participants |
51.5; 42.6 | — |
| SECONDARY Progression-free Survival (PFS) in the ITT Analysis Set |
6.9; 6.2 | — |
| SECONDARY Overall Response Rate (ORR) in the ITT Analysis Set |
47.3; 40.5 | — |
| SECONDARY Duration of Response (DOR) in PD-L1 Positive Participants |
10.0; 6.9 | — |
| SECONDARY Duration of Response in the ITT Analysis Set |
8.6; 7.2 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) and Physical Functioning Scores |
1.35; -0.45; 0.93; -1.58; -2.47; -3.92 | — |
| SECONDARY Change From Baseline in EORTC QLQ-C30 Fatigue Score |
1.75; 3.07; 1.71; 4.73 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module QLQ-STO22 (EORTC QLQ-STO22) |
-1.71; -0.61; -1.84; -0.22; -2.78; -1.27 | — |
| SECONDARY Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS) |
2.9; 0.8; 3.0; -0.8 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
495; 486; 211; 179 | — |
| SECONDARY Disease Control Rate in PD-L1 Positive Participants |
88.3; 83.1 | — |
| SECONDARY Disease Control Rate in the ITT Analysis Set |
89.8; 83.3 | — |
| SECONDARY Clinical Benefit Rate (CBR) in PD-L1 Positive Participants |
65.0; 59.2 | — |
| SECONDARY Clinical Benefit Rate (CBR) in the ITT Analysis Set |
63.1; 58.9 | — |
| SECONDARY Time to Response (TTR) in PD-L1 Positive Participants |
1.4; 1.4 | — |
| SECONDARY Time to Response (TTR) in the ITT Analysis Set |
1.4; 1.4 | — |
Summary
This study was designed to compare the efficacy and safety of tislelizumab plus chemotherapy versus placebo plus chemotherapy as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Eligibility Criteria
Key Inclusion Criteria
- Locally advanced unresectable or metastatic gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed adenocarcinoma
- No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. NOTE: Participants may have received prior neoadjuvant or adjuvant therapy as long as it was completed and have no recurrence or disease progression for at least 6 months.
- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1 within 7 days prior to randomization
- Adequate organ function ≤ 7 days prior to randomization
Key Exclusion Criteria
- Has squamous cell or undifferentiated or other histological type GC
- Active leptomeningeal disease or uncontrolled brain metastasis
- Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
- Prior therapy with an anti-programmed cell death protein-1 (PD-1), anti-programmed cell death protein ligand-1 (PD-L1), anti-programmed cell death protein ligand-2 (PD-L2), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03777657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.