BeOne Medicines announces EC approved Tevimbra to treat NSCLC

BeOne Medicines (ONC) announced that the European Commission, or EC, has approved Tevimbra, or tislelizumab, in combination with platinum-containing chemotherapy as neoadjuvant treatment followed by Tevimbra monotherapy as adjuvant treatment, for adult patients with resectable non-small cell lung cancer, or NSCLC, at high risk of recurrence. The EC approval is based on results from the Phase 3 RATIONALE-315 trial. The preplanned final analysis of RATIONALE-315 demonstrates that Tevimbra, combined with platinum-based chemotherapy before surgery and continued as monotherapy afterward, showed statistically significant and clinically meaningful benefit in overall survival, or OS, compared with chemotherapy combined with placebo. Data from this trial will be presented as a Late-Breaking Abstract at the IASLC 2025 World Conference on Lung Cancerhosted by the International Association for the Study of Lung Cancer in Barcelona, Spain, September 6-9. Building on the RATIONALE-315 results previously reported at the European Society for Medical Oncology Congress Virtual Plenary in February 20242 and published in The Lancet Respiratory Medicine3, which showed the dual primary endpoints of event-free survival and major pathologic response were met at the interim analyses, key findings from the final analysis include: With a median trial follow-up of 38.5 months, the Tevimbra-based regimen showed a statistically significant and clinically meaningful benefit in OS versus the chemotherapy + placebo arm; the significant EFS benefit previously reported with TEVIMBRA versus chemotherapy + placebo was sustained in this analysis, and this improvement was consistent across both independent review committe and investigator assessments, reinforcing the consistency and robustness of the findings. OS and EFS benefits were observed across major sub-groups, regardless of PD-L1 expression, disease stage, and histology. As reported at the interim analyses, the trial showed a clinically meaningful and statistically significant improvement in EFS, MPR and pathological complete response (pCR) vs. chemotherapy + placebo.