SAN MATEO, Calif. --- October 4, 2024---BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that TEVIMBRA® (tislelizumab-jsgr) is now available for commercial sale in the U.S. for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. At launch, the majority of eligible patients will have access to TEVIMBRA immediately through their insurance plans.
“At BeiGene, making our medicines accessible is central to our vision to provide life-changing medicines to people worldwide,” said Matt Shaulis, General Manager, North America at BeiGene. “BeiGene purposefully priced TEVIMBRA 10% lower than other anti-PD-1 therapies approved in this indication in an effort to make that vision a reality for ESCC patients in the U.S.”
TEVIMBRA was approved by the FDA earlier this year. The approval was based on the RATIONALE-302 trial, which met its primary endpoint in the intention-to-treat (ITT) population with a statistically significant and clinically meaningful survival benefit for TEVIMBRA compared with chemotherapy. In the ITT population, the median overall survival (OS) in the TEVIMBRA arm was 8.6 months (95% CI: 7.5, 10.4) compared to 6.3 months (95% CI: 5.3, 7.0) in the chemotherapy arm (p=0.0001; hazard ratio [HR]=0.70 [95% CI: 0.57, 0.85]). The safety profile of TEVIMBRA was favorable over chemotherapy.[1] The most common (≥20%) adverse reactions for TEVIMBRA, including laboratory abnormalities, were increased glucose, decreased hemoglobin, decreased lymphocytes, decreased sodium, decreased albumin, increased alkaline phosphatase, anemia, fatigue, increased AST, musculoskeletal pain, decreased weight, increased ALT and cough.1
BeiGene understands that living with cancer takes support. The myBeiGene patient support program can help simplify access to TEVIMBRA, answer questions about treatment, and provide personalized assistance plans through a dedicated Oncology Nurse Advocate. For more information about myBeiGene, visit https://www.mybeigene.com/patient/program-participation/.
TEVIMBRA is currently under review by the FDA for additional indications: first-line treatment of patients with locally advanced unresectable and metastatic ESCC and gastric/gastroesophageal junction (G/GEJ) cancers.
About TEVIMBRA® (tislelizumab-jsgr)
Tislelizumab is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.
About BeiGene
BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter), and Facebook.