BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company set to rebrand as BeOne Medicines, today announced that the European Commission has approved TEVIMBRA® (tislelizumab) in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC) and gastric or esophagogastric junction (G/GEJ) adenocarcinoma.
Professor Florian Lordick, Director of the University Cancer Center Leipzig, Germany, highlighted the urgency for effective treatments for patients with advanced gastric or esophageal cancer, who face survival times measured in months. He emphasized that the RATIONALE-305 and 306 studies demonstrate TEVIMBRA’s unique clinical profile and its potential to improve patient outcomes.
For ESCC, the expanded indication applies to TEVIMBRA combined with platinum-based chemotherapy for adult patients with unresectable, locally advanced or metastatic cancer with PD-L1 expression and a tumor area positivity (TAP) score of ≥5%. For G/GEJ adenocarcinoma, the approval applies to TEVIMBRA in combination with platinum- and fluoropyrimidine-based chemotherapy for adult patients with unresectable, locally advanced or metastatic HER2-negative cancer, also with a PD-L1 TAP score of ≥5%.
Mark Lanasa, MD, BeiGene’s Chief Medical Officer for Solid Tumors, remarked, “TEVIMBRA is a cornerstone of our solid tumor portfolio, and its approval across six indications in the EU over the past year underscores our commitment to providing innovative treatments to cancer patients worldwide.”
The ESCC indication is based on the RATIONALE-306 study (NCT03783442), which demonstrated that TEVIMBRA with chemotherapy significantly improved overall survival (OS) compared to placebo. In this Phase 3 trial, 649 patients were enrolled across Europe, North America, and Asia-Pacific, showing a 34% reduction in the risk of death, with a median OS of 17.2 months for TEVIMBRA compared to 10.6 months for placebo.
For G/GEJ adenocarcinoma, the approval is based on the RATIONALE-305 study (NCT03777657), which included 997 patients. The study showed a 20% reduction in the risk of death for patients treated with TEVIMBRA plus chemotherapy, with median OS of 15.0 months compared to 12.9 months for the placebo group. In patients with PD-L1 ≥5%, OS improved further, with a 29% reduction in the risk of death.
Safety data from over 2,800 patients indicated that the most common grade 3 or 4 adverse events for TEVIMBRA with chemotherapy included neutropenia, anemia, and pneumonia.
TEVIMBRA is also approved in the EU for the treatment of unresectable, locally advanced, or metastatic ESCC after prior chemotherapy, and for multiple non-small cell lung cancer indications.
BeiGene recently announced its plan to rebrand as BeOne Medicines, signaling its ongoing commitment to the development of innovative cancer treatments and collaboration with global partners to reach as many patients as possible.
About Gastric and Gastroesophageal Junction (G/GEJ) Adenocarcinoma
Gastric cancer is the fifth most common cancer worldwide, with nearly 1 million new cases diagnosed in 2022. G/GEJ adenocarcinoma occurs where the esophagus meets the stomach, often leading to poor prognosis due to late diagnosis.
About Esophageal Squamous Cell Carcinoma (ESCC)
Esophageal cancer, the sixth leading cause of cancer-related death globally, often presents as advanced or metastatic disease at diagnosis. With a five-year survival rate under 6% for distant metastases, there is a significant need for improved treatments.
About TEVIMBRA (Tislelizumab)
TEVIMBRA is an anti-PD-1 monoclonal antibody designed to minimize Fcγ receptor binding, helping the immune system target and fight tumors. Approved in 42 countries, TEVIMBRA has treated over 1.3 million patients globally as part of BeiGene’s solid tumor portfolio, with ongoing clinical trials involving approximately 14,000 patients across 66 studies.
