Swiss oncology company BeOne Medicines Ltd (NASDAQ: ONC) (HKEX: 06160; SSE: 688235) announced on Monday that it has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency for the use of TEVIMBRA (tislelizumab) in combination with platinum-based chemotherapy as neoadjuvant therapy, followed by adjuvant monotherapy, for adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence.

The recommendation is based on results from the Phase 3 RATIONALE-315 trial, which showed a statistically significant and clinically meaningful improvement in event-free survival and major pathological response. Among patients receiving the TEVIMBRA regimen, 56.2% achieved a major pathological response and 40.7% achieved pathological complete response, versus 15.0% and 5.7% in the placebo arm respectively. Event-free survival hazard ratio was 0.56, with early data indicating a positive trend in overall survival.

Safety data from the trial showed no new signals, with grade ≥3 treatment-related adverse events occurring in 72.1% of patients in the TEVIMBRA arm, consistent with known profiles. Surgical outcomes were unaffected by the neoadjuvant approach.

TEVIMBRA is already approved in the European Union across multiple NSCLC and small cell lung cancer indications, both in first- and second-line settings, and in other cancers including gastric, esophageal and nasopharyngeal carcinoma.

BeOne Medicines is advancing a broad oncology pipeline with nearly 14,000 patients enrolled globally in its TEVIMBRA development program. The company aims to expand access to cancer therapies across diverse markets.