BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading China-based biotechnology company, has announced that it has received market approval in China for its programmed death-1 (PD-1) inhibitor Tevimbra (tislelizumab). The National Medical Products Administration (NMPA) has granted approval for tislelizumab in combination with platinum-containing chemotherapy as both neoadjuvant therapy and post-surgery adjuvant therapy alone for patients with resectable stage II or IIIA non-small cell lung cancer (NSCLC).
This approval follows the positive results from the multi-center, randomized, placebo-controlled, double-blind Phase III RATIONALE 315 study, which evaluated the efficacy and safety of tislelizumab combined with platinum-containing chemotherapy as neoadjuvant therapy for resectable stage II or IIIA NSCLC, followed by tislelizumab as adjuvant therapy alone. The study achieved its dual primary endpoints, demonstrating significant improvements in event-free survival (EFS, HR: 0.56, 95% CI: 0.40-0.79) and major pathological response rate (MPR rate: 56.2% vs 15.0%). This confirms that the combination of perioperative tislelizumab and neoadjuvant chemotherapy can substantially reduce the risk of perioperative progression or recurrence and metastasis in patients. Additionally, perioperative treatment with tislelizumab significantly improved the pathological complete response rate (pCR rate, 40.7% vs 5.7%), and a positive trend towards prolonged overall survival (OS) was observed (HR: 0.62, 95% CI: 0.39-0.98). The treatment regimen showed good overall tolerability, with no new safety signals detected.
Since receiving its first marketing approval in China in December 2019, the PD-1 monoclonal antibody (mAb) has garnered 14 indication approvals, including its first US approval in September of last year.- Flcube.com
