Evidence Level:Sensitive: B - Late Trials
Title:
Rationale 305: Phase 3 study of tislelizumab plus chemotherapy vs placebo plus chemotherapy as first-line treatment (1L) of advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
Excerpt:Of 546 PD-L1+ patients enrolled...TIS+ICC showed statistically significant and clinically meaningful OS improvement vs P+ICC (HR 0.74 [95% CI: 0.59-0.94], mOS 17.2 vs 12.6 mo; 1-sided P= .0056). Compared with P+ICC, TIS+ICC also had longer PFS (mPFS 7.2 vs 5.9 mo; HR 0.67 [95% CI: 0.55-0.83]), higher ORR (50.4% vs 43.0%), and more durable response (mDoR 9.0 vs 7.1 mo)....In RATIONALE 305, TIS+ICC provided significant and clinically meaningful improvement in OS vs P+ICC with well acceptable safety as 1L in PD-L1+ patients with advanced GC/GEJC.
DOI:10.1200/JCO.2023.41.3_suppl.286
Evidence Level:Sensitive: B - Late Trials
Title:
BeiGene Announces Positive Findings from Phase 3 Trial of Tislelizumab in Combination with Chemotherapy in First-Line Gastric or Gastroesophageal Junction Cancer
Excerpt:BeiGene...announced positive findings from the global Phase 3 RATIONALE 305 trial of tislelizumab versus placebo in combination with chemotherapy as a first-line treatment for patients with locally advanced...The addition of tislelizumab to chemotherapy significantly extended the overall survival for previously untreated patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumor expressed PD-L1.
Evidence Level:Sensitive: C1 - Off-label
(Approved for Esophageal Squamous Cell Carcinoma)
New
Title:
TEVIMBRA Approved in U.S. for First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma in Combination with Chemotherapy
Excerpt:TEVIMBRA® (tislelizumab-jsgr), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1)
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma
Excerpt:...Overall Survival in PD-L1 Positive Participants`Overall Survival in the Intent-to-Treat (ITT) Analysis Set...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Surufatinib in Combination With Tislelizumab in Advanced Solid Tumors Surufatinib en combinación con tislelizumab en tumores sólidos avanzados
Excerpt:...Patients in dose expansion: must be able to provide a minimum of 10 unstained slides for central confirmation of PD-L1 expression and microsatellite stability testing. ...
More C2 evidence

Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
A Single-Center, Open-Label, Phase II Study of Tislelizumab + SOX Regimen as a New Adjuvant Long-Course Treatment for Locally Advanced Gastric Cancer/Gastric Cardia Adenocarcinoma
Excerpt:...The tumor was detected by the central laboratory to express PD-L1, and the tumor proportion score (CPS) was >=1;...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Investigate the impact of intratumoral neutrophils on gastric cancer patients undergoing neoadjuvant immunotherapy