By Fineline Cube BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) announced that the global Phase III RATIONALE 301 study evaluating tislelizumab in first – line unresectable hepatocellular carcinoma (HCC) has met its primary endpoint. The study demonstrated that the programmed death – 1 (PD – 1) inhibitor tislelizumab was non – inferior to sorafenib in terms of overall survival (OS). The safety profile was consistent with previous studies, with no safety warnings reported. The trial enrolled over 600 patients from the US, Europe, and Asia.
Study Details
The randomized RATIONALE 301 study compared the efficacy of tislelizumab with sorafenib in first – line unresectable HCC. The primary endpoint was the non – inferiority comparison of OS between the two treatment groups. Key secondary endpoints included the overall response rate (ORR) assessed by the blinded independent review committee (BIRC). Other secondary endpoints covered efficacy assessment, health – related quality of life measures, as well as safety and tolerability.
Global Development
Tislelizumab, which is subject to over 22 potential regulatory clinical studies, has enrolled more than 11,000 subjects from 30 countries in its global trials. The drug is being developed to treat solid tumors and blood cancers, either as a monotherapy or in combination with other drugs.-Fineline Info & Tech