- BeiGene Ltd BGNE global phase 3 study RATIONALE 305 reached its primary endpoint overall survival with tislelizumab in combination with chemotherapy in patients with advanced, unresectable, or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, regardless of PD-L1 status.
- No new safety signals have been identified for tislelizumab.
- BeiGene had previously announced superior OS for the combination versus chemotherapy in the PD-L1 high group in a planned interim analysis, and the study continued according to pre-designated statistical hierarchy tests.
- Also read: BeiGene’s Tislelizumab Demonstrates Non-Inferiority in Overall Survival, Safety vs. Standard of Care in Solid Tumors.
- Finally, tislelizumab in combination with chemotherapy demonstrated superior overall survival compared to chemotherapy in the intent-to-treat (ITT) population.
- Tislelizumab is currently under review by the FDA and the European Medicines Agency (EMA) for advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy.
- EMA is also evaluating tislelizumab for advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy and in combination with chemotherapy for previously untreated advanced or metastatic NSCLC.
- Price promotion: BGNE shares are down 1.37% on the last check Thursday to $254.95.
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