Shanghai Henlius Biotech (HKG: 2696) has announced the completion of the first subject dosing in a head-to-head bridging study for its programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab). The study is evaluating serplulimab as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) against Roche’s PD-L1 inhibitor Tecentriq (atezolizumab), the current standard of care in the United States.
Study Details
The head-to-head study is expected to enroll 200 subjects and will compare the efficacy and safety of serplulimab combined with carboplatin plus etoposide versus atezolizumab combined with carboplatin plus etoposide. This trial aims to demonstrate the potential advantages of HanSiZhuang in treating ES-SCLC, a condition with significant unmet medical needs.
Regulatory and Clinical Progress
Serplulimab has already been approved in China for treating unresectable or metastatic microsatellite highly unstable (MSI-H) solid tumors that have failed standard therapy, as well as for use in combination with chemotherapy for first-line squamous non-small cell lung cancer (sqNSCLC). Supplementary New Drug Applications (sNDAs) for serplulimab in combination with chemotherapy for first-line ES-SCLC and first-line esophageal squamous cell carcinoma (ESCC) were accepted for review in China in April and August 2022, respectively. Multiple clinical studies for the drug are ongoing globally, highlighting Henlius’ commitment to advancing cancer treatments.-Fineline Info & Tech
