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Association details:
Biomarker:PD-L1 expression
Cancer:Gastric Cancer
Drug:Tevimbra (tislelizumab) (PD1 inhibitor)
Direction:Sensitive
Evidence:
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).

Published date:
01/17/2023
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.
Secondary therapy:
Chemotherapy
DOI:
10.1200/JCO.2023.41.3_suppl.286
Trial ID:
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

Published date:
01/24/2022
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.
Secondary therapy:
Chemotherapy
Trial ID:
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. ...