BeiGene has announced that the U.S. Food and Drug Administration (FDA) has approved Tevimbra (tislelizumab), 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 is based on findings from BeiGene’s RATIONALE-306 trial, a randomized, placebo-controlled, double-blind, global Phase 3 study evaluating the efficacy and safety of Tevimbra combined with platinum-containing chemotherapy as a first-line treatment for adults (n=649) with unresectable, locally advanced recurrent, or metastatic ESCC. The trial met its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) for patients receiving Tevimbra plus chemotherapy compared to those receiving placebo plus chemotherapy. Exploratory analyses revealed that the OS improvement in the intent-to-treat (ITT) population was largely driven by results in the PD-L1 positive (≥1) subgroup.
In the PD-L1 positive population (n=481), the median OS was 16.8 months for patients treated with Tevimbra plus chemotherapy, compared to 9.6 months for those receiving placebo plus chemotherapy, representing a 34% reduction in the risk of death. These results mark a significant advancement in OS for first-line ESCC patients.
The safety profile of Tevimbra in combination with chemotherapy was assessed in the same RATIONALE-306 trial. The most frequent serious adverse reactions (≥2%) included pneumonia, dysphagia, diarrhea, fatigue, and esophageal stenosis. Common adverse reactions (≥20%) were anemia, fatigue, decreased appetite, nausea, constipation, weight loss, diarrhea, peripheral sensory neuropathy, vomiting, and stomatitis.
Tevimbra is also approved in the U.S. as a monotherapy for treating adults with unresectable or metastatic ESCC who have previously undergone systemic chemotherapy without a PD-(L)1 inhibitor. Additionally, it is approved in combination with chemotherapy for the first-line treatment of gastric and gastroesophageal junction (G/GEJ) cancers.
BeiGene recently announced plans to rebrand as BeOne Medicines Ltd., reaffirming its mission to develop innovative cancer treatments and collaborate globally to reach as many patients as possible.
About Esophageal Squamous Cell Carcinoma (ESCC)
Esophageal cancer ranks as the sixth leading cause of cancer-related deaths worldwide, with ESCC being the most common subtype, accounting for nearly 90% of cases. Projections estimate 957,000 new esophageal cancer cases by 2040, a nearly 60% increase from 2020, highlighting the urgent need for effective therapies. Esophageal cancer is often fatal, with over two-thirds of patients diagnosed at advanced or metastatic stages. The five-year survival rate for those with distant metastases is less than 6%.
About Tevimbra (tislelizumab)
Tevimbra is a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody, uniquely designed with high affinity and specificity for PD-1. It is engineered to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, enhancing the immune system’s ability to detect and combat tumors.