China-Based Biotech BeiGene Scores FDA Approval For Tevimbra/Chemo Combo For Untreated Patients With Esophageal Cancer

Core Insights - BeiGene Ltd announced FDA approval for Tevimbra (tislelizumab-jsgr) in combination with platinum-containing chemotherapy for first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [1] - The approval is based on the results from the RATIONALE-306 Phase 3 study, which demonstrated a statistically significant improvement in overall survival (OS) for patients treated with Tevimbra compared to placebo [2][3] Study Results - The RATIONALE-306 study met its primary endpoint, showing a median OS of 16.8 months for patients treated with Tevimbra plus chemotherapy versus 9.6 months for those on placebo plus chemotherapy, resulting in a 34% reduction in the risk of death [3] - The improvement in OS was primarily observed in the subgroup of patients with PD-L1 expression ≥1 [2] Previous Approvals - In December, the FDA also approved Tevimbra for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1, based on the RATIONALE-305 Phase 3 trial [4] - The RATIONALE-305 study showed a median OS of 15.0 months for patients treated with Tevimbra compared to 12.9 months for those on placebo, resulting in a 20% reduction in the risk of death [5] Market Reaction - Following the announcement, BeiGene's stock (ONC) was observed to be up 3.04% at $253 during the premarket session [5]