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European Commission Approves TEVIMBRA® for First-Line Treatment of ESCC and G/GEJ Adenocarcinoma

NextEdge Admin

28 Nov 2024

2 min 31 sec

European Commission,esophageal carcinoma,gastric adenocarcinoma,precision oncology

BeiGene, Ltd. soon to be renamed BeOne Medicines Ltd., announced that the European Commission has approved TEVIMBRA® (tislelizumab) in combination with chemotherapy for first-line treatment of esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

The approvals are based on compelling results from the global RATIONALE-305 and 306 Phase 3 trials. In ESCC, TEVIMBRA with platinum-based chemotherapy showed a median overall survival (OS) of 17.2 months compared to 10.6 months with placebo plus chemotherapy, a 34% reduction in the risk of death (HR: 0.66). For patients with G/GEJ adenocarcinoma, TEVIMBRA with chemotherapy demonstrated a median OS of 15.0 months versus 12.9 months for placebo plus chemotherapy, reducing the risk of death by 20% (HR: 0.80). Both indications are for patients with PD-L1-expressing tumors (TAP score ≥ 5%).

The safety profile of TEVIMBRA was consistent with prior studies, with the most common Grade 3 or 4 adverse reactions including neutropenia, thrombocytopenia, anemia, fatigue, and pneumonitis. Over 2,800 patients have been treated with TEVIMBRA, either as monotherapy or in combination therapies.

TEVIMBRA is already approved in the EU for other indications, including unresectable or metastatic ESCC after prior platinum-based chemotherapy and three non-small cell lung cancer settings. Mark Lanasa, M.D., Ph.D., BeiGene’s Chief Medical Officer, emphasized the company's focus on expanding access to innovative treatments, noting the significant survival benefits TEVIMBRA offers.

This milestone aligns with BeiGene’s mission to improve outcomes for cancer patients globally. The planned name change to BeOne Medicines underscores its commitment to collaboration and innovation in oncology.