BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has been approved in China as a first-line therapy for non-resectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). This approval comes as part of a combination therapy including chemotherapy regimens of paclitaxel and platinum or fluorouracil and platinum. This marks the 11th approval for tislelizumab in China to date.
RATIONALE 306 Study Results Lead to Approval
The approval is supported by the positive results from the RATIONALE 306 study, a randomized, placebo-controlled, double-blind global Phase III study that enrolled 649 patients across the Asia-Pacific, Europe, and North America. The study demonstrated that patients receiving tislelizumab in combination with chemotherapy achieved statistically and clinically significant improvements in overall survival (OS), with a median OS of 17.2 months compared to 10.6 months for those receiving chemotherapy and placebo. Patients treated with tislelizumab combined with chemotherapy had a 34% lower risk of death, highlighting the therapy’s efficacy. The safety profile of the combination therapy with tislelizumab was consistent with previous trials.
Tislelizumab’s Broadening Indications in China
Tislelizumab’s previously approved ten indications in China encompass a range of cancers, including third-line classical Hodgkin’s lymphoma (cHL), metastatic urothelial carcinoma (UC), first-line squamous non-small cell lung cancer (NSCLC) combined with chemotherapy, second-line therapy for hepatocellular carcinoma (HCC), first-line non-squamous NSCLC, and other solid tumors with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). The drug is also awaiting regulatory decisions for the treatment of first-line HCC, further expanding its potential impact on cancer treatment in China.-Fineline Info & Tech
