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Investing.com -- BeOne Medicines AG (NASDAQ:ONC) stock fell 3.2% following the European Commission’s approval of TEVIMBRA (tislelizumab) for treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence.
The approval is based on the Phase 3 RATIONALE-315 trial, which demonstrated that TEVIMBRA, combined with platinum-based chemotherapy before surgery and continued as monotherapy afterward, showed statistically significant overall survival benefits compared to chemotherapy with placebo. With a median follow-up of 38.5 months, the TEVIMBRA-based regimen showed an OS benefit with a hazard ratio of 0.65 versus the chemotherapy plus placebo 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 was consistent with previous analyses, with no new safety signals identified. The most common Grade 3 or 4 treatment-related adverse events in both treatment arms were decreased neutrophil count and decreased white blood cell count.
This approval adds to TEVIMBRA’s existing EU approvals in multiple lung cancer indications, including first-line treatment for squamous NSCLC, first-line treatment for non-squamous NSCLC with high PD-L1 expression, treatment after prior platinum-based therapy, and first-line treatment for extensive-stage small cell lung cancer.
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