FDA Approves Tevimbra, BeiGene’s Treatment for Adults with Unresectable or Metastatic Esophageal Squamous Carcinoma

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The FDA has approved BeiGene’s Tevimbra (tislelizumab-jsgr) for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have previously undergone systemic chemotherapy excluding PD-L1 inhibitors. The FDA based the approval on findings from the Phase III RATIONALE 302 trial (NCT03430843), which showed a significant survival benefit with Tevimbra compared to chemotherapy, with an overall survival rate of 8.6 months compared with 6.3 months in patients administered chemotherapy. Further, the treatment was found to be safer altogether, with manageable adverse effects.¹

“Today’s FDA approval of Tevimbra for patients with ESCC who have previously received chemotherapy, along with its ongoing review of our [biologics license application] for first line ESCC patients, represents a significant step in our commitment to bringing this therapy to more patients around the world,” said Mark Lanasa, MD, PhD, chief medical officer, solid tumors, BeiGene, in a press release. “As BeiGene’s first drug candidate produced through our immuno-oncology program and second approved medicine in the US, Tevimbra is poised to be a critical pillar of our solid tumor development program, which spans more than 17 registration-enabling clinical trials in more than 30 countries across regions globally.”

Last September, the European Commission approved Tevimbra for the treatment of ESCC after prior platinum-based chemotherapy. The FDA is reviewing further applications for the drug as a first-line treatment for ESCC and for gastric or gastroesophageal junction adenocarcinoma, with a final decision expected to be announced later this year.^1,2

“Tevimbra is the cornerstone of BeiGene’s solid tumor portfolio. We believe having full control of the development and commercialization of Tevimbra will allow us to rapidly accelerate our plans and reach more patients worldwide,” said Josh Neiman, chief commercial officer, North America and Europe, BeiGene, in a press release. “We look forward to bringing Tevimbra to people living with advanced or metastatic ESCC, an aggressive disease with limited treatment options.”

According to the American Cancer Society, approximately 22,370 new esophageal cancer cases have been diagnosed in the US in 2024. Additionally, an estimated 16,130 have died from it. Statistics show that esophageal cancer is more common among men, with chances for men being around 1 in 127 while women have a 1 in 434 chance of getting it. Despite esophageal cancer making up only 1% of all cancers diagnosed in the US, it is much more common in areas such as parts of China, Iran, Africa, and India.³

“Patients diagnosed with advanced or metastasized ESCC, the most common histologic subtype of esophageal cancer, often progress following initial therapy and are in need of new options,” said Syma Iqbal, MD, associate professor, clinical medicine, section chief gastrointestinal oncology, division of medical oncology, cancer physician in chief, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, in the press release. “The RATIONALE 302 trial showed that patients with previously treated ESCC who received Tevimbra saw a clinically meaningful survival benefit, highlighting its potential as an important treatment option for these patients.”

Tevimbra is expected to be available in the United States by the second half of 2024.¹

References

1. BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy. BeiGene. March 14, 2024. Accessed March 15, 2024. https://ir.beigene.com/news/beigene-receives-fda-approval-for-tevimbra-for-the-treatment-of-advanced-or-metastatic-esophageal-squamous/20eb032c-15ce-456a-a852-39c88a28d811/

2. BeiGene Announces Positive Regulatory Updates in Europe and the U.S. After Recently Regaining Global Rights for TEVIMBRA®. BeiGene. September 19, 2023. Accessed March 15, 2024. https://ir.beigene.com/news/beigene-announces-positive-regulatory-updates-in-europe-and-the-u-s-after-recently-regaining-global-rights/5e4692d6-d726-4989-a659-49dc97d4d7ed/

3. Key Statistics for Esophageal Cancer. American Cancer Society. January 19, 2024. Accessed March 15, 2024. https://www.cancer.org/cancer/types/esophagus-cancer/about/key-statistics.html