BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235), a China-based biopharmaceutical company, has announced that the global RATIONALE 305 trial has successfully met its primary endpoint of overall survival. The trial demonstrated that tislelizumab, in combination with chemotherapy, showed superior overall survival (OS) compared to chemotherapy alone in patients with advanced unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ), irrespective of PD-L1 status. Importantly, no new safety signals were identified for tislelizumab.
Interim Results and Final Analysis
Interim results had previously indicated that in patients with GC/GEJ who had high PD-L1 expression, the combination of tislelizumab and chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS compared to placebo plus chemotherapy. The median OS was 17.2 months for the tislelizumab group versus 12.6 months for the placebo group, with a hazard ratio (HR) of 0.74 (95% confidence interval 0.59, 0.94); P=0.0056. In the final analysis, tislelizumab combined with chemotherapy continued to show superior OS compared to chemotherapy in the intent-to-treat (ITT) population, reinforcing the therapy’s potential as a treatment option for these patient groups.-Fineline Info & Tech
