TEVIMBRA Approved in U.S. for Advanced Esophageal Cancer with Chemotherapy
BeiGene, Ltd. (NASDAQ: ONC; 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) in combination with platinum-based chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1).
BeiGene, a global biotechnology company focused on developing innovative therapies for cancer, announced today that the U.S. Food and Drug Administration (FDA) has approved its immunotherapy treatment, TEVIMBRA® (tislelizumab-jsgr), in combination with platinum-based chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). This approval marks a significant milestone in the ongoing efforts to improve outcomes for patients battling ESCC, a cancer type with few effective treatment options.
Dr. Nataliya Uboha, Associate Professor at the University of Wisconsin, Carbone Cancer Center, expressed excitement about the approval, saying, “The approval of TEVIMBRA in combination with chemotherapy for adult patients with ESCC expands first-line treatment options for patients with this disease. There is a critical need for effective treatments of ESCC, and TEVIMBRA has been shown to improve outcomes in this patient population.” The combination therapy, which targets PD-L1-expressing tumors, addresses an unmet need for patients whose tumors are resistant to traditional treatments.
The approval of TEVIMBRA in combination with chemotherapy is based on the positive results from BeiGene’s global, randomized, placebo-controlled, double-blind Phase 3 RATIONALE-306 study (NCT03783442), which included 649 patients. The study aimed to assess the efficacy and safety of TEVIMBRA when combined with platinum-based chemotherapy as a first-line treatment for patients with unresectable, locally advanced, recurrent, or metastatic ESCC. The study met its primary endpoint, showing a statistically significant improvement in overall survival (OS) for patients receiving TEVIMBRA plus chemotherapy compared to those receiving chemotherapy alone.
Results from the study’s exploratory analyses showed that the survival benefit was most prominent in the subgroup of patients whose tumors expressed PD-L1 at a level of ≥1. Among these patients (n=481), the median OS was 16.8 months for those treated with TEVIMBRA plus chemotherapy, compared to just 9.6 months for those receiving placebo with chemotherapy. This represents a 34% reduction in the risk of death (HR: 0.66, 95% CI: 0.53, 0.82), marking an unprecedented improvement in survival for first-line ESCC patients.
Mark Lanasa, M.D., Ph.D., Chief Medical Officer of Solid Tumors at BeiGene, commented on the approval: “Today’s approval, our third from the FDA in less than a year, reflects our dedication to advancing innovative therapies and addressing critical needs in cancer care. The FDA’s approval of TEVIMBRA for the first-line treatment of advanced esophageal squamous cell carcinoma is a significant step forward in tackling the unmet needs in this challenging disease area. We are grateful to the patients, clinicians, and researchers whose commitment and courage have made this progress possible.”
The safety profile of TEVIMBRA in combination with chemotherapy was evaluated in the same clinical trial. The most frequent serious adverse events (≥2%) included pneumonia, dysphagia, diarrhea, fatigue, and esophageal stenosis. Common side effects (≥20%) included anemia, fatigue, decreased appetite, nausea, constipation, weight loss, diarrhea, peripheral sensory neuropathy, vomiting, and stomatitis. These side effects are consistent with those typically observed in cancer patients receiving chemotherapy and immunotherapy.
In addition to this new approval, TEVIMBRA is already approved in the U.S. for use as a monotherapy for adult patients with unresectable or metastatic ESCC who have previously received systemic chemotherapy that did not include a PD-(L)1 inhibitor. It is also approved for the first-line treatment of adults with gastric and gastroesophageal junction (G/GEJ) cancers in combination with chemotherapy.
The company also recently announced its intention to change its name to BeOne Medicines Ltd., reinforcing its ongoing commitment to the development of cutting-edge cancer therapies that aim to eliminate cancer and improve patient outcomes worldwide.
About Esophageal Squamous Cell Carcinoma (ESCC)
Esophageal cancer is the sixth leading cause of cancer-related deaths globally, with ESCC accounting for nearly 90% of esophageal cancer cases. Projections indicate that by 2040, there will be an estimated 957,000 new cases of esophageal cancer, representing a nearly 60% increase from 2020. The majority of patients are diagnosed with advanced or metastatic disease, with less than a 6% five-year survival rate for those with distant metastases. These statistics highlight the urgent need for new and effective treatments for ESCC.
About TEVIMBRA® (tislelizumab-jsgr)
TEVIMBRA is a humanized IgG4 anti-PD-1 monoclonal antibody that is specifically designed to enhance the immune system’s ability to recognize and attack tumor cells while minimizing potential immune-related side effects. It has shown potential across a variety of tumor types and is currently being evaluated in multiple ongoing clinical trials. The global TEVIMBRA clinical development program includes nearly 14,000 patients across 66 trials, with 20 registration-enabling studies. It is approved in over 42 countries, and more than 1.3 million patients have been treated with TEVIMBRA globally.
This approval by the FDA represents a major step forward in advancing treatment options for ESCC and underscores the potential of innovative immunotherapies in addressing the unmet needs of cancer patients worldwide.
