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BeiGene Receives Positive CHMP Opinions for TEVIMBRA® as First-Line Treatment for Advanced G/GEJ Cancer and ESCC

NextEdge Admin

22 Oct 2024

2 min 16 sec

BeiGene, Ltd. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued positive opinions recommending extended authorization for TEVIMBRA® (tislelizumab). This includes its use as a first-line treatment for HER2-negative, locally advanced, or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma and esophageal squamous cell carcinoma (ESCC).

For G/GEJ cancer, the recommendation supports TEVIMBRA with platinum- and fluoropyrimidine-based chemotherapy for adult patients with PD-L1-expressing tumors (TAP score ≥ 5%). In ESCC, it is recommended with platinum-based chemotherapy for patients with similar PD-L1 expression. Both approvals are based on positive survival outcomes from BeiGene’s Phase 3 RATIONALE-305 and 306 trials, respectively.

RATIONALE-305 showed TEVIMBRA extended median overall survival (OS) to 15.0 months compared to 12.9 months with placebo (HR: 0.80). For patients with PD-L1 ≥ 5%, the OS benefit increased to 16.4 months. In the RATIONALE-306 trial, TEVIMBRA achieved a median OS of 17.2 months versus 10.6 months with placebo (HR: 0.66), representing a 34% reduction in the risk of death.

TEVIMBRA, approved in the EU for ESCC and non-small cell lung cancer (NSCLC), demonstrated manageable safety, with common adverse effects including neutropenia, anemia, and fatigue. "We are committed to delivering new options for patients with poor prognosis cancers," said Mark Lanasa, BeiGene's Chief Medical Officer.

These recommendations bring TEVIMBRA closer to becoming a standard treatment for G/GEJ cancer and ESCC in Europe.