China-based biopharmaceutical company BeiGene Ltd (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab). This new approval allows the use of tislelizumab in combination with platinum and fluoropyrimidine-based chemotherapy to treat first-line unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1 (≥1).
RATIONALE-305 Study Results Support FDA Approval
The FDA’s decision is supported by the results from the RATIONALE-305 study, a global Phase III, randomized, double-blinded, placebo-controlled trial that assessed the efficacy and safety of tislelizumab in combination with chemotherapy for first-line advanced unresectable or metastatic gastric cancer/ gastroesophageal junction cancer (GC/GEJC). The study met its primary endpoint, showing that tislelizumab combined with chemotherapy resulted in a significant overall survival (OS) benefit, with a median OS of 15.0 months compared to 12.9 months for placebo combined with chemotherapy, representing a 20% reduction in the risk of death.
Previous Approvals and Ongoing Reviews for Tislelizumab
Tislelizumab was previously approved in the US in March of this year for the treatment of unresectable or metastatic esophageal squamous cell carcinoma (ESCC) in patients who had previously received systemic chemotherapy without prior PD-(L)1 inhibitor treatment. Additionally, the market filing for the first-line treatment of locally advanced, unresectable or metastatic ESCC is currently under review by the FDA.-Fineline Info & Tech
