BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has revealed that its programmed death-1 (PD-1) inhibitor tislelizumab has been approved in China as a first-line therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (G/GEJ) tumors where PD-L1 is overexpressed. Specifically, tislelizumab is approved for use in combination with fluorouracil plus platinum chemotherapy. This marks the tenth approval for tislelizumab in China.
Clinical Trial Results
The approval was supported by interim results from the randomized, double-blind, placebo-controlled global Phase III RATIONALE 305 study. The results demonstrated that in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with high PD-L1 expression, the tislelizumab regimen produced statistically and clinically significant improvements in overall survival (OS). The median OS was 17.2 months compared to 12.6 months for the placebo combined with chemotherapy (P=0.0056). The regimen also exhibited controllable safety characteristics, with no new safety signals observed. The trial remains double-blinded to further evaluate the overall survival benefit in the intention-to-treat (ITT) population.
Regulatory and Market Status
Tislelizumab is currently subject to over 20 regulatory studies across 35 countries. It was first approved for marketing in China in December 2019 and was included in the National Reimbursement Drug List (NRDL) in 2020. The drug now covers five indications in China. However, tislelizumab has not yet obtained market approval outside of China.
Strategic Implications
The expanded approval of tislelizumab for G/GEJ tumors highlights BeiGene’s ongoing commitment to advancing cancer treatments and improving patient outcomes. This approval further solidifies tislelizumab’s position in the Chinese market and underscores BeiGene’s leadership in the development of innovative oncology therapies. The company’s extensive regulatory efforts and clinical trials are expected to contribute to the global expansion of tislelizumab, potentially bringing this effective treatment to patients worldwide.-Fineline Info & Tech
