First patient treated with Henlius' anti-PD-1 mAb serplulimab in Europe in the MRCT phase 3 study for the first-line treatment of LS-SCLC

2023-10-27 07:12:06

Shanghai (ots/PRNewswire) – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient in Europe in the international multicenter Phase 3 clinical trial (NCT05353257) of the self-developed anti-PD-1 mAb HANSIZHUANG (serplulimab) in combination with Chemotherapy and concurrent radiotherapy were treated in patients with advanced-stage small cell lung cancer (LS-SCLC) in the EU country of Latvia. So far, the first patients have been treated in China, the USA, Australia and other countries and regions.

According to GLOBOCAN 2020, lung cancer (LC) is the second most diagnosed cancer worldwide and the one with the highest mortality. Recently, HANSIZHUANG was recommended for the treatment of ES-SCLC in the 2022 CSCO Guidelines for the Diagnosis and Treatment of Small Cell Lung Cancer. Henlius continues to explore immuno-oncology therapy for LS-SCLC with the goal of providing patients with more effective treatment.

HANSIZHUANG is the first innovative mAb developed by Henlius. It was approved by the NMPA for the treatment of MSI-H solid tumors, non-small cell lung cancer (sqNSCLC) and ES-SCLC, and esophageal squamous cell carcinoma (ESCC) and has since been proven in 40,000 patients in China. In terms of unmet clinical needs, Henlius covers the full spectrum of first-line treatment of LC. Two global, multicenter Phase 3 clinical trials of sqNSCLC and ES-SCLC were conducted in China, Turkey, Poland, Georgia and other countries and regions, with over 30% of the total enrolled subjects being white, providing greater case diversity clinical research offers. ASTRUM-005, the international multicenter phase 3 study in patients with ES-SCLC, was conducted in JAMA, one of the four leading medical journals in the world. This makes ASTRUM-005 the first in JAMA published study on immunotherapy for SCLC. In addition, HANSIZHUANG has received orphan drug designation from the US Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of SCLC. The European Medicines Agency (EMA) has validated the application for HANSIZHUANG in combination with chemotherapy for the first-line treatment of ES-SCLC. It is worth noting that the first patient was treated in a bridging head-to-head study in the US comparing HANSIZHUANG with standard therapy atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC.

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