BeiGene (NASDAQ: BGNE) announced that a supplementary Biologic License Application (sBLA) for its programmed death-1 (PD-1) inhibitor tislelizumab has been accepted for review by the Center for Drug Evaluation (CDE). The application seeks approval for tislelizumab in combination with chemotherapy as a first-line treatment for advanced or metastatic gastric or gastroesophageal junction (GC/GEJ) adenocarcinoma with tumors expressing PD-L1.
Clinical Trial Basis
The sBLA is supported by positive interim results from the RATIONALE 305 study, a global Phase III trial involving 997 patients from 13 countries. This randomized, double-blind, placebo-controlled study compared tislelizumab combined with chemotherapy against placebo with chemotherapy. The primary endpoint was overall survival (OS), with secondary endpoints including progression-free survival (PFS), overall response rate (ORR), duration of response (DoR), and safety.
Interim Results
Interim analysis revealed that the tislelizumab and chemotherapy combination met the primary OS endpoint in PD-L1-expressing patients. Safety profiles were consistent with previous trials, with no new safety signals identified.
Existing Approvals
Tislelizumab holds nine other indications in China, including full market approvals for first-line advanced squamous and non-squamous NSCLC, both in combination with chemotherapy, and as a monotherapy for second- or third-line NSCLC. Conditional approvals have been granted for classical Hodgkin’s lymphoma, metastatic urothelial carcinoma, hepatocellular carcinoma, microsatellite instability-high/mismatch repair deficient solid tumors, esophageal squamous cell carcinoma, and nasopharyngeal carcinoma.-Fineline Info & Tech
