FDA Approves BeiGene's Tevimbra Combo for Gastric Cancer

The U.S. Food and Drug Administration (FDA) has granted approval for BeiGene's PD-1 inhibitor, Tevimbra (tislelizumab-jsgr), as a component of first-line combination therapy aimed at advanced gastric cancer. This authorization allows the drug to be used in conjunction with chemotherapy that includes platinum and fluoropyrimidine for treating adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma, particularly in cases where the tumors express PD-L1.

Globally, gastric cancer is recognized as the fifth most prevalent cancer, with an anticipated 27,000 new patients projected in the United States for the year 2024. Tevimbra is engineered to assist the body's immune mechanisms in identifying and combating cancerous growths. Prior to this recent development, the drug had already gained approval in the U.S. as a standalone treatment for adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) that had previously been treated with systemic chemotherapy lacking a PD-(L)1 inhibitor.

The FDA's endorsement of the therapy was backed by encouraging outcomes from the RATIONALE-305, a late-stage clinical trial. In this study, Tevimbra, combined with a chemotherapy regimen chosen by investigators, demonstrated a 20% reduction in the risk of mortality when compared to a placebo plus chemotherapy for patients suffering from advanced forms of unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Mark Lanasa, the Chief Medical Officer for solid tumors at BeiGene, highlighted the drug's approval, marking it as the second U.S. approval in 2024. He emphasized the potential of Tevimbra to meet significant needs in cancer treatment. This decision follows closely on the heels of the European Commission's endorsement, which also approved Tevimbra for use with platinum- and fluoropyrimidine-based chemotherapy as a first-line therapy for adults with HER2-negative gastric or gastroesophageal junction adenocarcinoma, whether locally advanced, unresectable, or metastatic.

Additionally, the European Union's regulatory body approved the use of Tevimbra in combination with platinum-based chemotherapy specifically for adult patients with unresectable, locally advanced, or metastatic ESCC as a first-line treatment. Currently, there is a pending application with the FDA to expand the use of Tevimbra as a first-line treatment for adults with locally advanced unresectable or metastatic ESCC.

Expressing gratitude, Lanasa acknowledged the pivotal role played by patients, clinicians, and researchers in reaching this milestone. He expressed optimism for continued advancements in cancer treatment as the company looks forward to further developments in 2025.