BeiGene announces acceptance of a supplemental biologics license application in China for tislelizumab in second- or Third-line NSCLC.

BeiGene, Ltd. announced that a supplemental Biologics License Application (sBLA) for anti-PD1 antibody tislelizumab was accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for treatment in the second- or third-line setting of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on paltinum based therapies. The sBLA is supported by clinical results from the Phase III RATIONALE 303 trial, a randomized, open-label, multicenter global Phase III clinical trial (NCT03358875) designed to evaluate the efficacy and safety of tislelizumab compared to docetaxel in the second- or third-line setting in patients with locally advanced or metastatic NSCLC who have progressed on a prior platinum-based chemotherapy. The primary endpoint of the trial is OS in all patients (the ITT population) and in patients with high PD-L1 expression; key secondary endpoints include objective response rate (ORR), duration of response (DoR), progression-free survival (PFS), and safety. A total of 805 patients in 10 countries across Asia, Europe, the Americas, and Oceania were randomized 2:1 to either the tislelizumab arm or the docetaxel arm.