Shanghai Henlius Pharmaceutical Co., Ltd (HKG: 2696) has announced receiving another indication approval from China’s National Medical Products Administration (NMPA) for its PD-1 inhibitor, HanSiZhuang (serplulimab). The drug is now approved for use in combination with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), marking the first global approval of a PD-1 checkpoint inhibitor for first-line SCLC treatment. This is the third indication for serplulimab, following previous approvals for microsatellite highly unstable (MSI-H) solid tumors and squamous non-small cell lung cancer (sqNSCLC).
Data from ASTRUM-005 Study
The approval is supported by data from the ASTRUM-005 study, a randomized, double-blind, placebo-controlled global multi-center Phase III trial involving 585 subjects from 128 centers across China, Turkey, Poland, Georgia, and other regions, with 31.5% of participants being Caucasian. The study demonstrated that the median overall survival (OS) for the serplulimab/chemotherapy group reached 15.8 months, a significant 4.7-month extension compared to the control group. The risk of death was reduced by 38% (HR=0.62, 95% CI: 0.50~0.76). Among the Asian population, the median OS was 15.9 months, 4.8 months longer than the control group (HR=0.63, 95% CI: 0.49~0.81). The median progression-free survival (PFS), evaluated by the Independent Review Committee (IRC) according to RECIST v1.1, was also extended (5.8 vs. 4.3 months; HR 0.47, 95% CI: 0.38~0.58). The results confirmed that the serplulimab/chemotherapy combination achieved the pre-set endpoints in first-line ES-SCLC, with a favorable safety and tolerability profile.
Implications and Future Outlook
The approval of serplulimab for first-line ES-SCLC underscores Henlius’ commitment to advancing cancer treatment options, particularly in addressing the significant unmet needs in small cell lung cancer. With this milestone, Henlius continues to expand its presence in the oncology space, leveraging robust clinical data to support the global adoption of its innovative therapies. The company remains focused on further exploring the potential of serplulimab across multiple indications, aiming to improve outcomes for patients with various forms of cancer.-Fineline Info & Tech
