Gastric Cancer: TEVIMBRA Approved in U.S. for First-Line Treatment
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company set to change its name to BeOne Medicines Ltd., today announced that the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr) for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults. The approval allows the use of TEVIMBRA in combination with platinum and fluoropyrimidine-based chemotherapy for patients whose tumors express PD-L1 (≥1).
“We are excited about today’s approval of TEVIMBRA for the treatment of gastric cancer or gastroesophageal junction cancers in PD-L1 positive adult patients. This is the second approval for TEVIMBRA in the U.S. this year and reinforces its transformative potential in oncology,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer for Solid Tumors at BeiGene. “We are deeply grateful to the patients, clinicians, and researchers whose commitment has made this progress possible. We are enthusiastic about the momentum this creates and look forward to continuing to advance our work in 2025.”
The FDA approval for first-line G/GEJ cancer is based on the results of the global Phase 3 RATIONALE-305 trial (NCT03777657), which evaluated the efficacy and safety of TEVIMBRA in combination with platinum and fluoropyrimidine-based chemotherapy. The randomized, double-blind, placebo-controlled study demonstrated a statistically significant overall survival (OS) benefit for patients treated with TEVIMBRA compared to placebo. The median OS for patients receiving TEVIMBRA and chemotherapy was 15.0 months, versus 12.9 months for those on placebo and chemotherapy (n=997; hazard ratio: 0.80, 95% CI: 0.70, 0.92; P=0.0011), showing a 20% reduction in the risk of death.
The safety profile of TEVIMBRA in this combination treatment was based on pooled data from 1,972 patients across several clinical studies. The most common Grade 3 or 4 adverse reactions for patients receiving TEVIMBRA plus chemotherapy included neutropenia, anemia, thrombocytopenia, fatigue, pneumonia, and diarrhea, among others. The findings confirm TEVIMBRA’s ability to improve survival in gastric cancer and gastroesophageal junction cancer, while demonstrating manageable safety in a clinical setting.
TEVIMBRA, a humanized anti-PD-1 monoclonal antibody, has been designed with high affinity and binding specificity for PD-1, minimizing unwanted immune responses through reduced binding to Fc-gamma receptors. This helps the body’s immune cells effectively target and destroy tumor cells. TEVIMBRA is also approved in the U.S. as monotherapy for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have not received prior PD-(L)1 inhibitor treatment. Additionally, a Biologics License Application (BLA) for TEVIMBRA’s use as a first-line treatment for metastatic ESCC is currently under FDA review.
The approval of TEVIMBRA in gastric cancer and gastroesophageal junction cancer adds to the company’s robust pipeline and supports its commitment to expanding cancer treatment options. BeiGene also recently announced its intention to change its name to BeOne Medicines Ltd., reflecting its ongoing dedication to the fight against cancer through innovation and collaboration with global partners.
About Gastric and Gastroesophageal Junction Cancer
Gastric cancer is the fifth most common cancer globally and the fifth leading cause of cancer-related deaths. In 2022, nearly 1 million new cases were diagnosed worldwide, with 660,000 deaths. In the U.S., it is estimated that approximately 27,000 new cases of gastric cancer and 11,000 deaths will occur in 2024. Gastric cancer remains a significant health burden. Gastroesophageal junction cancer, occurring at the point where the esophagus joins the stomach, shares similar symptoms and treatment approaches with gastric cancer.
About TEVIMBRA® (tislelizumab-jsgr)
TEVIMBRA is an anti-PD-1 monoclonal antibody designed to treat a variety of cancers by enhancing the immune system’s ability to recognize and eliminate tumor cells. It is part of BeiGene’s solid tumor portfolio and has been evaluated in over 13,000 patients in clinical trials across 66 studies worldwide. TEVIMBRA is approved in more than 42 countries, and over 1.3 million patients have been treated with this innovative therapy.
With ongoing trials in multiple cancer indications, TEVIMBRA shows promise for the treatment of various tumor types, including gastric cancer, and continues to be a cornerstone of BeiGene’s oncology development program. Through its global clinical trials and expanding regulatory approvals, TEVIMBRA is set to play a crucial role in reshaping gastric cancer treatment.
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