Shanghai Henlius Biotech (HKG: 2696) has announced the completion of the first subject dosing in a global Phase III clinical study comparing its programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab) combined with chemotherapy and concurrent radiotherapy to placebo combined with chemotherapy and concurrent radiotherapy in limited stage-small cell lung cancer (LS-SCLC). This marks a significant milestone in the development of this innovative therapy for a challenging form of lung cancer.
Clinical Trial Design and Objectives
Eligible subjects will be randomly divided into two groups at a ratio of 1:1. The primary objective of the multi-region clinical trial (MRCT) is to evaluate the anti-tumor effect of HanSiZhuang combined with chemotherapy and concurrent radiotherapy in patients with LS-SCLC. The primary endpoint is overall survival (OS), with secondary endpoints including progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR). Safety and immunogenicity will also be assessed by the investigator according to RECIST 1.1.
Regulatory and Development Milestones
Serplulimab has been approved in China for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) solid tumors that have failed standard therapy, as well as for use in combination with chemotherapy in first-line squamous non-small cell lung cancer (sqNSCLC). Supplementary New Drug Applications (sNDAs) for the drug in combination with chemotherapy for first-line extensive-stage small cell lung cancer (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 currently underway globally.
Future Outlook
The completion of the first dosing in the Phase III study for HanSiZhuang underscores Henlius Pharmaceutical’s commitment to advancing innovative treatments for lung cancer. With demonstrated efficacy and safety in previous studies, HanSiZhuang is poised to address significant unmet needs in the treatment of limited stage-small cell lung cancer. Henlius’ ongoing efforts in clinical development highlight its dedication to improving patient outcomes in oncology.-Fineline Info & Tech
