TEVIMBRA Approved in U.S. for Initial Treatment of Gastric and GE Junction Cancers with Chemotherapy

In a significant medical advancement, BeiGene, Ltd., a global leader in oncology, has announced the approval of its drug TEVIMBRA® (tislelizumab-jsgr) by the U.S. Food and Drug Administration (FDA). This approval marks a pivotal development in the treatment of advanced gastric cancers, specifically for adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. The treatment combines TEVIMBRA with platinum and fluoropyrimidine-based chemotherapy, targeting tumors that express PD-L1 (≥1).

The approval is based on the outcomes of a comprehensive global Phase 3 trial known as RATIONALE-305. This trial was a randomized, double-blind, placebo-controlled study designed to assess the effectiveness and safety of TEVIMBRA in combination with chemotherapy as a first-line treatment for adults with advanced stages of gastric or gastroesophageal junction cancer. The study demonstrated a substantial improvement in overall survival rates, with patients receiving the TEVIMBRA combination showing a median overall survival of 15.0 months compared to 12.9 months for those who received a placebo plus chemotherapy. This translates to a 20% reduction in the risk of death for patients treated with TEVIMBRA.

The safety profile of TEVIMBRA was examined through pooled data from multiple studies, involving 1,972 patients. Common serious adverse effects observed in patients treated with TEVIMBRA alongside chemotherapy included neutropenia, thrombocytopenia, anemia, and fatigue, among others.

Previously, TEVIMBRA had already been approved in the United States as a monotherapy for treating adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) following systemic chemotherapy that excluded PD-(L)1 inhibitors. An additional application is under review for its use as a first-line treatment for advanced ESCC.

BeiGene, soon to be renamed BeOne Medicines Ltd., continues to emphasize its mission of providing innovative cancer treatments. The company is committed to expanding access to its medicines globally, as reflected in its ongoing partnerships and extensive clinical development programs. Globally, TEVIMBRA has been approved in over 42 countries and has benefited more than 1.3 million patients. The drug is part of BeiGene's broad portfolio aimed at making cancer treatment more accessible and effective.

Gastric cancer remains a significant health challenge as the fifth most common cancer worldwide and one of the leading causes of cancer-related deaths. In 2022, nearly one million new cases were diagnosed globally, with a high mortality rate. The five-year survival rate for gastric cancer in the U.S. is approximately 36%, underscoring the urgent need for effective treatments like TEVIMBRA.

TEVIMBRA is uniquely engineered as a humanized IgG4 monoclonal antibody that targets the programmed cell death protein 1 (PD-1) with high specificity, designed to avoid binding to Fc-gamma receptors on macrophages. This design enhances the ability of the immune system to recognize and attack tumor cells, making it a promising treatment option in various cancer settings.

BeiGene’s global workforce of nearly 11,000 employees is dedicated to innovation in oncology, striving to provide more affordable and accessible treatment options to cancer patients worldwide. As the company transitions to BeOne Medicines Ltd., its focus remains on broadening the reach and impact of its therapeutic offerings, reinforcing its role as a leader in the fight against cancer.