BeiGene, Ltd. announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental Biologics License Application (sBLA) for anti-PD-1 antibody tislelizumab in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC). The sBLA is supported by clinical results from a randomized, double-blind, Phase 3 clinical trial RATIONALE 309 (NCT03924986) to evaluate the efficacy and safety of tislelizumab combined with gemcitabine and cisplatin versus placebo combined with gemcitabine and cisplatin as a first-line treatment for patients with recurrent or metastatic NPC. The primary endpoint of this trial is progression-free survival (PFS) as assessed by independent review committee (IRC) in the intention-to-treat (ITT) population; secondary endpoints include overall survival (OS), IRC-assessed overall response rate (ORR) and duration of response (DoR), and investigator-assessed PFS. A total of 263 Asian patients were enrolled and randomized 1:1 to either the tislelizumab plus chemotherapy arm or the placebo plus chemotherapy arm. As announced in May 2021, RATIONALE 309 met the primary endpoint of PFS at the planned interim analysis. The safety profile of tislelizumab was consistent with its known risks, with no new safety signals identified with the addition of chemotherapy.