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FDA Approves TEVIMBRA® for First-Line Treatment of PD-L1-Positive Gastric and Gastroesophageal Junction Cancers

NextEdge Admin

28 Dec 2024

2 min 38 sec

BeiGene, Ltd.,adenocarcinoma,oncology,Precision Medicine

BeiGene, Ltd., a global oncology company soon to be renamed BeOne Medicines Ltd., announced FDA approval for TEVIMBRA® (tislelizumab-jsgr) combined with platinum and fluoropyrimidine-based chemotherapy as a first-line treatment for unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in PD-L1-positive adults. This marks TEVIMBRA’s second U.S. approval in 2024.

Approval is based on the RATIONALE-305 Phase 3 trial, which demonstrated a median overall survival (OS) of 15.0 months with TEVIMBRA plus chemotherapy versus 12.9 months with placebo plus chemotherapy, reducing the risk of death by 20% (HR: 0.80; P=0.0011). The study enrolled 997 patients globally. TEVIMBRA’s safety profile was evaluated across multiple studies involving 1,972 patients, with common Grade 3 or 4 adverse reactions including neutropenia, anemia, fatigue, pneumonia, and rash.

TEVIMBRA is also approved as monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior chemotherapy. A BLA for first-line ESCC treatment is under FDA review. The drug is a humanized IgG4 monoclonal antibody targeting PD-1 with high binding specificity, designed to minimize interaction with Fc-gamma receptors and enhance immune detection of tumors.

G/GEJ cancer is the fifth most common cancer globally, with nearly 1 million new cases and 660,000 deaths in 2022. In the U.S., approximately 27,000 patients were diagnosed in 2024, with a five-year survival rate of 36%.

TEVIMBRA, the cornerstone of BeiGene’s solid tumor portfolio, has treated over 1.3 million patients worldwide. It is approved in more than 42 countries, supported by extensive clinical trials involving nearly 14,000 patients across 66 studies. The company remains committed to advancing innovative therapies for cancer patients globally.