The FDA approved BeiGene’s TEVIMBRA (tislelizumab-jsgr), combined with chemotherapy, for first-line treatment of advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults with PD-L1-positive tumors. This approval is based on the positive results from the RATIONALE-305 Phase 3 trial, which showed a significant overall survival benefit for patients receiving TEVIMBRA plus chemotherapy compared to chemotherapy alone. This marks the second FDA approval for TEVIMBRA in 2024, with the first being for esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy.
This approval is a critical advancement for patients with G/GEJ cancer, a disease with a limited number of effective treatment options and a relatively low five-year survival rate. The demonstrated overall survival benefit with TEVIMBRA offers new hope for patients facing this aggressive cancer. This also enhances the existing treatment landscape by providing a new first-line therapy option, potentially improving long-term outcomes for patients. This expanded indication reinforces the importance of PD-L1 biomarker testing in guiding treatment decisions for G/GEJ cancer, enabling more personalized and effective therapies.
The RATIONALE-305 trial demonstrated a 20% reduction in the risk of death in the TEVIMBRA group, with a median overall survival of 15 months compared to 12.9 months for the placebo group. Pooled safety data from various trials, which enrolled nearly 2,000 patients receiving TEVIMBRA, revealed common grade 3 or 4 adverse reactions, including neutropenia, thrombocytopenia, anemia, and fatigue, among others. The approval for this G/GEJ indication specifically targets patients whose tumors express PD-L1 with a tumor proportion score of 1 or more. Another Biologics License Application for TEVIMBRA is currently under review by the FDA for first-line treatment of advanced ESCC.
This second approval solidifies TEVIMBRA’s emerging position as a key player in the oncology landscape. It expands the therapeutic arsenal available to oncologists, providing a valuable new option for patients battling G/GEJ cancers. It also underscores the potential for further approvals and broader use of TEVIMBRA across various cancer types. This continued development of targeted therapies like TEVIMBRA holds significant promise for improving patient survival and quality of life.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
