First Patient Dosed for MRCT Phase 3 Study on First-Line LS-SCLC of Henlius Anti-PD-1 mAb Serplulimab in Europe

(Adnkronos) – SHANGHAI, Oct. 25, 2023 /PRNewswire/ — Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient in Europe has been dosed in the international multi-centre phase 3 clinical trial (NCT05353257) of the company's self-developed anti-PD-1 mAb HANSIZHUANG (serplulimab) in combination with chemotherapy and concurrent radiotherapy in patients with limited-stage small cell lung cancer (LS-SCLC) in EU country Latvia. Previously, the first patients in China, the U.S., Australia and other countries and regions have been dosed. According to GLOBOCAN 2020, lung cancer (LC) is the second most commonly diagnosed and the first mortality cancer around the world. Recently, HANSIZHUANG was recommended by the 2022 CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer for the treatment of ES-SCLC. Henlius is continuing to explore immuno-oncology therapy for LS-SCLC, with the goal of delivering more effective treatment for patients. HANSIZHUANG is the first innovative mAb developed by Henlius. It has been approved by the NMPA for the treatment of MSI-H solid tumours, non-small cell lung cancer (sqNSCLC) and ES-SCLC and esophageal squamous cell carcinoma (ESCC) and has since seen benefits in 40,000 patients in China. Regarding unmet clinical needs as a core, Henlius covers the full range of first-line treatments of LC. Two global multi-centre phase 3 clinical trials regarding sqNSCLC and ES-SCLC have been conducted in China, Turkey, Poland, Georgia, and other countries and regions, with over 30% of the total enrolled subjects being White, providing more diverse cases for clinical research. ASTRUM-005, the international multi-centre, phase 3 study in patients with ES-SCLC, has been published in JAMA, one of the top four medical journals in the world, making ASTRUM-005 became the first study published in JAMA on SCLC immunotherapy. Moreover, HANSIZHUANG has been granted orphan-drug designations for the treatment of SCLC by the United States Food and Drug Administration (FDA) and the European Commission (EC), respectively. 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 mentioning that the first patient has been dosed in a bridging head-to-head trial in the US to comparing HANSIZHUANG to standard of care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC, which is expected to propel the product towards US market approval further. 
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