Novartis: RATIONALE 306 Trial Meets Primary Endpoint At Interim Analysis

(RTTNews) - Novartis (NVS) reported positive topline results from an interim analysis of the phase III RATIONALE 306 study, which showed anti-PD-1 immune checkpoint inhibitor tislelizumab plus chemotherapy significantly improved overall survival compared to chemotherapy in patients with previously untreated unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma regardless of PD-L1 expression.

Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, said: "We plan to discuss these data with health authorities, and we will continue to expand our tislelizumab clinical development program in pursuit of synergistic combinations with the ultimate goal of extending survival for more patients."

Tislelizumab is currently under review by the US FDA and the European Medicines Agency for advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy.