BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued positive opinions recommending an extended authorization for TEVIMBRA® (tislelizumab) in the treatment of gastric or gastroesophageal junction (G/GEJ) adenocarcinoma and esophageal squamous cell carcinoma (ESCC).
In the case of gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, the CHMP’s positive opinion supports the use of TEVIMBRA in combination with platinum- and fluoropyrimidine-based chemotherapy as a first-line treatment for adult patients with HER2-negative, locally advanced, unresectable, or metastatic G/GEJ cancer whose tumors express PD-L1 with a tumor area positivity (TAP) score of ≥ 5%. For esophageal squamous cell carcinoma (ESCC), the positive opinion allows TEVIMBRA to be used alongside platinum-based chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced, or metastatic ESCC with the same PD-L1 TAP score criteria.
“Survival rates for advanced gastric and esophageal cancers remain among the lowest, highlighting the urgent need for new treatment options,” said Prof. Florian Lordick, Director and Professor of Oncology at the University Cancer Center Leipzig, Germany. “The RATIONALE-305 and 306 trials demonstrated that tislelizumab combined with chemotherapy improves survival compared to placebo plus chemotherapy, showcasing its potential for better patient outcomes.”
“TEVIMBRA is a cornerstone of BeiGene’s solid tumor portfolio. We recently launched TEVIMBRA in the EU for first- and second-line non-small cell lung cancer (NSCLC) and second-line ESCC,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. “These CHMP opinions bring us closer to offering this innovative therapy to patients with untreated G/GEJ cancer and ESCC, who currently have limited treatment options.”
The extension of indication for first-line G/GEJ cancer is based on the RATIONALE-305 trial (NCT03777657), a randomized, double-blind, placebo-controlled global Phase 3 study assessing TEVIMBRA combined with chemotherapy. Enrolling 997 patients across Europe, North America, and Asia-Pacific, the trial met its primary endpoint, showing a statistically significant overall survival (OS) benefit with a median OS of 15.0 months for TEVIMBRA plus chemotherapy compared to 12.9 months for placebo plus chemotherapy (HR: 0.80; P=0.0011). In the PD-L1 ≥ 5% subgroup, median OS was 16.4 months for TEVIMBRA plus chemotherapy versus 12.8 months for placebo (HR: 0.71).
The indication extension for first-line ESCC is based on the RATIONALE-306 trial (NCT03783442), which enrolled 649 patients globally. This study also met its primary endpoint, demonstrating a significant OS benefit with median OS of 17.2 months for TEVIMBRA plus chemotherapy versus 10.6 months for placebo plus chemotherapy (HR: 0.66). The three-year OS in the PD-L1 ≥ 5% group showed substantial improvement as well (median 19.1 months for TEVIMBRA vs. 10.0 months for placebo; HR: 0.62).
Safety data included 1,534 patients who received TEVIMBRA monotherapy and 1,319 patients with G/GEJ cancer, ESCC, or NSCLC who received TEVIMBRA with various chemotherapies. Common Grade 3 or 4 adverse reactions included neutropenia, thrombocytopenia, anemia, fatigue, and pneumonia.
TEVIMBRA is already approved in the EU for advanced or metastatic ESCC after prior platinum-based chemotherapy and for three NSCLC indications.
About Gastric and Gastroesophageal Junction (G/GEJ) Adenocarcinoma
Gastric cancer is the fifth most common cancer globally, with nearly 1 million new cases and 660,000 deaths reported in 2022. Gastroesophageal junction adenocarcinoma occurs where the esophagus meets the stomach, just beneath the diaphragm.
About Esophageal Squamous Cell Carcinoma (ESCC)
Esophageal cancer is the sixth leading cause of cancer-related deaths worldwide, with ESCC being the most common subtype, accounting for nearly 90% of cases. The projected number of new cases is expected to rise to 957,000 by 2040, highlighting the urgent need for effective treatments. More than two-thirds of patients are diagnosed with advanced disease, facing a five-year survival rate of less than 6% for those with distant metastases.
