BeiGene's Tislelizumab/Chemo Combo Hits Primary Goal In Gastric Cancer Study

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  • BeiGene Ltd's BGNE global RATIONALE 305 Phase 3 trial met its primary endpoint of 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 were identified for tislelizumab.
  • BeiGene previously announced superior OS for the combination compared with chemotherapy in the PD-L1 high group at a planned interim analysis, and the trial continued according to pre-specified statistical hierarchy testing. 
  • Also Read: BeiGene's Tislelizumab Shows Non-Inferiority In Overall Survival, Safety Vs. Standard Treatment In Solid Tumors.
  • In the final analysis, tislelizumab, in combination with chemotherapy, demonstrated superior OS compared with 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. 
  • The EMA is also reviewing 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 Action: BGNE shares are down 1.37% at $254.95 on the last check Thursday.
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