BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that its anti-PD-1 therapy, tislelizumab, has received approval from the National Medical Products Administration (NMPA) in China for the first-line treatment of locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction (G/GEJ) in combination with fluorouracil and platinum-based chemotherapy.
The regulatory approval is supported by the final analysis results of the RATIONALE-305 study, which set a new benchmark for survival rates in advanced gastric cancer among both global and Chinese patient populations. The study demonstrated that in the global intention-to-treat (ITT) population, the median overall survival (mOS) with tislelizumab in combination with chemotherapy was 15.0 months, representing a 20% reduction in the risk of death. Notably, the mOS for the Chinese population reached 15.7 months. Previously approved in China in February 2023 for PD-L1 overexpressing, locally advanced unresectable or metastatic gastric/gastroesophageal junction (G/GEJ) tumors, this latest approval expands the treatment to include first-line gastric cancer patients irrespective of PD-L1 expression status.
Tislelizumab has now garnered 13 indication approvals in China, with two additional filings under regulatory review and 11 indications already covered by the National Reimbursement Drug List (NRDL). Internationally, in the US, the drug received accelerated approval in February of this year for the treatment of unresectable or metastatic esophageal squamous cell carcinoma (ESCC) in patients who had previously received systemic chemotherapy but had not been treated with a PD-(L)1 inhibitor.- Fineline.com
