In a significant stride for cancer treatment, BeiGene, Ltd., a global oncology leader soon to rebrand as BeOne Medicines Ltd., announced the U.S. Food and Drug Administration (FDA) approval of Tevimbra (tislelizumab-jsgr). The therapy, used in combination with platinum and fluoropyrimidine-based chemotherapy, has been greenlit as a first-line treatment for unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults with PD-L1 expression (≥1).

A Milestone in Cancer Care

Mark Lanasa, M.D., Ph.D., Chief Medical Officer for Solid Tumors at BeiGene, celebrated the approval, stating, “This FDA approval of Tevimbra marks a significant step forward in our mission to deliver transformative therapies to cancer patients. It underscores Tevimbra’s potential to address critical oncology needs.” The approval follows a second U.S. endorsement of Tevimbra in 2024, signaling the drug’s growing prominence in cancer care.

Groundbreaking Clinical Results

Tevimbra’s approval is based on data from the RATIONALE-305 trial, a global Phase 3 study that evaluated the efficacy of Tevimbra combined with chemotherapy. The trial demonstrated a statistically significant improvement in overall survival (OS). Patients receiving Tevimbra and chemotherapy achieved a median OS of 15.0 months compared to 12.9 months in the placebo group, translating to a 20% reduction in mortality risk (HR: 0.80 [95% CI: 0.70, 0.92]; P=0.0011).

Comprehensive Safety Data

Safety evaluations included data from nearly 2,000 patients across multiple studies. Common Grade 3 or 4 adverse reactions included neutropenia, thrombocytopenia, anemia, fatigue, and pneumonia. Notably, immune-mediated adverse reactions such as pneumonitis, colitis, and hepatitis require vigilant monitoring and prompt management.

Expanding Oncology Horizons

Tevimbra, already approved in the U.S. for unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior chemotherapy, is under FDA review for first-line ESCC treatment. Globally, Tevimbra has reached over 1.3 million patients across 42 countries, bolstered by ongoing clinical trials involving nearly 14,000 participants.

Gastric and GEJ Cancer: A Global Health Challenge

Gastric cancer ranks as the fifth most common cancer worldwide, with nearly 1 million new diagnoses in 2022 and over 660,000 deaths. In the U.S., approximately 27,000 people were diagnosed in 2024, with a five-year survival rate of just 36%. Gastroesophageal junction cancer, affecting the esophagus-stomach connection, also poses significant health risks.

About Tevimbra

Tevimbra is a humanized immunoglobulin G4 (IgG4) anti-PD-1 monoclonal antibody designed to enhance the immune system’s ability to fight tumors. Its innovative design minimizes binding to Fc-gamma receptors, reducing adverse immune responses. The drug’s development portfolio encompasses 66 global trials, 20 of which are registration-enabling studies.

Commitment to Innovation

BeiGene’s upcoming name change to BeOne Medicines Ltd. reflects its dedication to combating cancer through collaboration and innovative solutions. The company’s mission remains steadfast: to deliver cutting-edge therapies to as many patients as possible worldwide.