Positive new Phase III data on Novartis' tislelizumab in esophageal cancer

Today, Swiss pharma giant Novartis (NOVN: VX) announced results from the Phase III RATIONALE 306 trial showing tislelizumab plus chemotherapy significantly improved overall survival (OS) as a first-line treatment for adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC), regardless of PD-L1 status.

Tislelizumab plus chemotherapy demonstrated a median OS of 17.2 months (CI, 15.8-20.1 months) versus 10.6 months (CI, 9.3-12.1 months) in patients receiving chemotherapy plus placebo and reduced the risk of death by 34% (hazard ratio=0.66; CI, 0.54-0.80, p<0.0001). In collaboration with Sino-America biotech BeiGene (Nasdaq: BGNE), these data were presented today during a late-breaking oral session at the 2022 European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer.

Novartis has the rights to develop, manufacture and commercialize tislelizumab in North America, Europe and Japan through a  collaboration and license agreement with BeiGene, which has gained approval for marketing the drug in eight cancer indications in China, where tislelizumab generated sales of $255.1 million in full-year 2021.