BeiGene Ltd. said Wednesday that its Phase 3 trial of tislelizumab in combination with chemotherapy met the study's primary endpoint of overall survival in patients with previously untreated advanced or metastatic esophageal squamous cell carcinoma.
The biopharmaceutical company said the safety and tolerability profile for tislelizumab in combination with chemotherapy at this interim analysis was consistent with previous trials and no new safety signals were identified.
Tislelizumab is currently under review by the U.S. Food and Drug Administration and the European Medicines Agency for advanced or metastatic ESCC after prior chemotherapy. The EMA is also reviewing tislelizumab for advanced or metastatic non-small cell lung cancer after prior chemotherapy, and in combination with chemotherapy for previously untreated advanced or metastatic NSCLC.
In January, BeiGene announced a collaboration with Novartis to accelerate the clinical development and marketing of tislelizumab in North America, Europe, and Japan.
Tislelizumab is approved by the China National Medical Products Administration as a treatment for eight indications, including a recent approval for use in patients with locally advanced or metastatic ESCC who have disease progression or are intolerant to first-line standard chemotherapy. Tislelizumab isn't approved for use outside of China.
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