Research & Development
Shanghai Henlius Biotech doses first patient in United States NCT05468489 study of HANSIZHUANG
30 November 2022 -

Shanghai Henlius Biotech, Inc. (2696.HK), a subsidiary of China-based Shanghai Fosun Pharmaceutical (Group) Co Ltd, announced on Tuesday that it has dosed its first patient in NCT05468489, a bridging head-to-head trial in the United States comparing HANSIZHUANG (serplulimab), an innovative anti-PD-1 monoclonal antibody (mAb) independently developed by the firm to standard of care Atezolizumab (anti-PD-L1 mAb) for the treatment of extensive-stage small cell lung cancer (ES-SCLC).

The company is planning to recruit 100 pairs of US subjects with ES-SCLC to assess the efficacy of HANSIZHUANG. The subjects are being enrolled based on the positive feedback of FDA Biologics license Application (BLA) submission for HANSIZHUANG for the treatment of ES-SCLC and the discussion outcomes of the FDA's Class C consultation meeting.

NCT05468489, a randomised, open-label clinical study, is intended to compare the efficacy and safety of serplulimab with atezolizumab (anti-PD-L1 mAb) when integrated with chemotherapy (carboplatin-etoposide) in earlier untreated US patients with ES-SCLC. The primary aim of the study is to compare the efficacy of the two treatment regimens in earlier untreated US ES-SCLC patients. The secondary aim is to assess the efficacy, safety, pharmacokinetics, and immunogenicity of serplulimab in combination with chemotherapy. The primary endpoint is overall survival (OS) while secondary endpoints include progression-free survival (PFS), PFS2, objective response rate (ORR), duration of response (DOR), safety, pharmacokinetic characteristics, and immunogenicity.