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

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.
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