BeOne Medicines to present data from Phase 3 trials RATIONALE-307 and 312

BeOne Medicines (ONC) announced the presentation of data from two pivotal Phase 3 trials – RATIONALE-307 and 312 – offering new evidence of the benefits of its PD-1 inhibitor, TEVIMBRA, or tislelizumab, at the European Society of Medical Oncology 2025 Congress, or ESMO 2025, in Berlin, Germany, October 17-21. The results reinforce TEVIMBRA’s consistent and durable efficacy across lung cancer subtypes, including non-small cell lung cancer, or NSCLC, and extensive-stage small cell lung cancer, or ES-SCLC. In addition, the first clinical data from BeOne’s investigational HPK1 inhibitor, BGB-26808, as a single agent and in combination with TEVIMBRA, will be presented, highlighting promising antitumor activity and a generally manageable safety and tolerability profile in patients with advanced solid tumors. The European Commission’s approvals of TEVIMBRA in lung cancer are based on five randomized Phase 3 studies from the RATIONALE program. At ESMO 2025, BeOne will present new data from two of these trials, further substantiating TEVIMBRA’s efficacy across lung cancer settings, including NSCLC and ES-SCLC, with a consistent safety profile. Long term data show TEVIMBRA plus chemotherapy significantly improved overall survival over chemotherapy alone across different subgroups of patients with locally advanced or metastatic squamous NSCLC, including patients with stage IV disease, irrespective of PD-L1 expression. These survival benefits were observed even in the presence of high in-study crossover from chemotherapy to TEVIMBRA, a factor that typically reduces the observed benefit of treatment.