BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has received approval in China for the first-line treatment of irresectable or metastatic hepatocellular carcinoma (HCC), marking the drug’s 12th indication approval in the country.
The approval is supported by the RATIONALE 301 study, a randomized, open-label, global Phase III trial that enrolled 674 patients from Asia, Europe, and the United States. The study demonstrated that tislelizumab showed non-inferiority in overall survival (OS) compared to sorafenib, with a median OS of 15.9 months for tislelizumab and 14.1 months for sorafenib. Tislelizumab also exhibited a higher objective response rate (ORR) of 14.3% versus 5.4% for sorafenib and a longer median response duration (DoR) of 36.1 months compared to 11.0 months. The safety profiles of tislelizumab and sorafenib were consistent with previous studies.
Last September, tislelizumab was approved in the European Union (EU) for the treatment of irresectable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) that has previously received platinum-containing chemotherapy, becoming the first home-grown PD-1 preparation to gain approval abroad.- Flcube.com
