BeOne Medicines AG (NASDAQ:ONC) stock fell 3.2% following the European Commission’s approval of TEVIMBRA (tislelizumab) for treating resectable non-small cell lung cancer (NSCLC) at high risk of recurrence.
The approval stems from the Phase 3 RATIONALE-315 trial, which showed that TEVIMBRA combined with platinum-based chemotherapy before surgery, followed by TEVIMBRA monotherapy, provided a statistically significant overall survival benefit compared with chemotherapy plus placebo. With a median follow-up of 38.5 months, the TEVIMBRA regimen demonstrated an OS advantage with a hazard ratio of 0.65 versus the control arm.
“Delivering a statistically significant overall survival benefit – a critical endpoint in oncology studies – alongside the European Commission’s approval of TEVIMBRA in perioperative resectable NSCLC marks a pivotal moment for patients and physicians,” said Mark Lanasa, Chief Medical Officer for Solid Tumors at BeOne. “As only the second PD-1 inhibitor to demonstrate an OS benefit in this setting, TEVIMBRA is poised to reshape lung cancer treatment in Europe.”
The drug’s safety profile remained consistent with prior studies, and no new safety concerns were identified. The most common Grade 3 or 4 treatment-related adverse events across both arms were reduced neutrophil and white blood cell counts.
This new approval expands TEVIMBRA’s existing European authorizations in several lung cancer indications, including: first-line treatment for squamous NSCLC, first-line treatment for non-squamous NSCLC with high PD-L1 expression, post-platinum therapy, and first-line treatment for extensive-stage small cell lung cancer.
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