BeOne Medicines reports positive opinion from CHMP regarding TEVIMBRA

BeOne Medicines (ONC) announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency issued a positive opinion recommending approval of TEVIMBRA, or tislelizumab, in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, for the treatment of adult patients with resectable non-small cell lung cancer, or NSCLC, at high risk of recurrence. This recommendation is based on the Phase 3 RATIONALE-315 study. RATIONALE-315 is a double-blind, placebo-controlled, multicenter, Phase 3 study that randomized 453 patients with resectable NSCLC 1:1 to receive either TEVIMBRA plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by TEVIMBRA as adjuvant treatment or placebo plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by placebo as adjuvant treatment. As previously reported at the European Society for Medical Oncology Congress Virtual Plenary in February 20241, the dual primary endpoints of event-free survival and major pathologic response (MPR) were met at the interim analyses of the RATIONALE-315 study. Results include Statistically significant and clinically meaningful improvement in MPR and pathological complete response, or pCR rates; statistically significant EFS and trend for overall survival, or OS benefits favoring TEVIMBRA in early data; consistent safety profile of the TEVIMBRA arm with that of individual therapies, with 72.1% of patients in the TEVIMBRA arm experiencing grade greater than or equal to3 treatment-related adverse events and 15.5% of patients in the TEVIMBRA arm experiencing serious TRAEs. There were no new safety signals identified with this regimen, and the most common Grade 3 or 4 TRAEs in the TEVIMBRA arm were decreased neutrophil count and decreased white blood cell count.