Shanghai Henlius Biotech (HKG: 2696) has announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for its programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab). The drug is filed for its first indication as a first-line treatment in combination with chemotherapy for extensive-stage small cell lung cancer (ES-SCLC).
Supporting Data from ASTRUM-005 Study
The filing is supported by data from the ASTRUM-005 study, a randomized, double-blinded, placebo-controlled global multi-center Phase III study. This study assessed the efficacy and safety of the treatment regimen in first-line ES-SCLC compared with placebo combined with chemotherapy. Conducted in 128 centers across China, Poland, Turkey, and Georgia, the study enrolled 585 subjects, with 31.5% being of Caucasian origin. The results were presented at the American Society of Clinical Oncology Annual Meeting and published online by the Journal of the American Medical Association. As of June 13, 2022, the median overall survival (OS) of the total population in the serplulimab group reached 15.8 months, setting a new global record for OS in first-line SCLC treatments, while maintaining a good safety profile.
Previous Recognition and Ongoing Studies
Serplulimab previously obtained Orphan Drug Designation (ODD) status for use in SCLC in the United States. The drug is currently undergoing multiple clinical studies globally, covering a range of cancers including lung cancer, esophageal cancer, head and neck squamous cell carcinoma, and gastric cancer.-Fineline Info & Tech
