Oncology company BeOne Medicines Ltd (NASDAQ:ONC) (HKEX:06160) (SSE:688235) announced on Thursday that the European Commission has approved TEVIMBRA (tislelizumab) in combination with gemcitabine and cisplatin as a first-line treatment for adults with metastatic or recurrent nasopharyngeal carcinoma not amenable to curative surgery or radiotherapy.

The approval is based on data from the Phase 3 RATIONALE-309 trial, which demonstrated a statistically significant improvement in progression-free survival. Patients receiving TEVIMBRA plus chemotherapy saw a 48% reduction in the risk of disease progression or death, with median progression-free survival of 9.2 months versus 7.4 months in the placebo arm.

An updated analysis showed consistent efficacy and a sustained overall survival benefit, with median overall survival reaching 45.3 months for the TEVIMBRA group compared to 31.8 months for placebo.

TEVIMBRA plus chemotherapy was generally well tolerated, and no new safety signals emerged. The most common Grade 3 or 4 adverse reactions were neutropenia, anaemia, and thrombocytopenia.

This marks the second European Union approval for TEVIMBRA in 2025, expanding its existing indications across gastric, oesophageal, small cell lung, and non-small cell lung cancers.