RATIONALE-305 (NCT03777657) is a randomized, double-blind, placebo-controlled, global Phase 3 trial comparing the efficacy and safety of tislelizumab combined with platinum and fluoropyrimidine chemotherapy to placebo combined with platinum and fluoropyrimidine chemotherapy as a first-line treatment for patients with advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).

This factsheet describes the final analysis of the Phase 3 RATIONALE-305 trial, where tislelizumab plus chemotherapy significantly improved overall survival (OS) in the intention-to-treat (ITT) population compared to chemotherapy alone. The safety profile of tislelizumab plus chemotherapy was manageable in patients with unresectable, locally advanced or metastatic GC/GEJC. No new safety signals were identified.

The RATIONALE-307, RATIONALE-304, and RATIONALE-303 trials were designed to evaluate the safety and efficacy of tislelizumab as a monotherapy and in combination with chemotherapy for the treatment of non-small cell lung cancer (NSCLC).

Download this factsheet to review the study design and key efficacy and safety takeaways.

Download this factsheet to learn more about tislelizumab, including approvals and regulatory filings, and pivotal clinical trials.

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