Pharma Focus Asia

The Phase 3 Clinical Trial for First-Line LS-SCLC Utilizing Henlius' Anti-PD-1 mAb Serplulimab Begins Patient Dosing in Europe

Thursday, October 26, 2023

Shanghai Henlius Biotech, Inc. (2696.HK) recently commenced a phase 3 clinical trial (NCT05353257) for their proprietary anti-PD-1 monoclonal antibody (mAb), HANSIZHUANG (serplulimab), in combination with chemotherapy and concurrent radiotherapy for patients with limited-stage small cell lung cancer (LS-SCLC) in Latvia, marking the first such trial in Europe. Leading the investigation are distinguished principal investigators, including Academician Jinming Yu of the Chinese Academy of Engineering and Director of Shandong Cancer Hospital, Ligang Xing, Vice Director of Shandong Cancer Hospital, and Ying Cheng, Director of Jilin Cancer Hospital. Previously, patients in China, the U.S., Australia, and other regions had been dosed in this trial.

Lung cancer is a global health concern, being the second most commonly diagnosed and deadliest cancer in the world, with 2.2 million new cases and 1.8 million deaths in 2020. Small cell lung cancer (SCLC) is a highly aggressive form, representing 15%-20% of lung cancer cases and known for its rapid progression and poor prognosis, especially in its limited stage. The standard treatment for limited-stage SCLC involves surgery, chemotherapy, and concurrent radiotherapy, but traditional chemotherapy has seen limited success, often leading to drug resistance and relapse. Immune checkpoint inhibitors have shown promise in extensive-stage SCLC but have not yet demonstrated efficacy in limited-stage SCLC. HANSIZHUANG, already approved for various cancer indications, is being explored as a treatment for limited-stage SCLC, with the aim of offering more effective therapy options.

HANSIZHUANG, Henlius's first innovative monoclonal antibody, has been approved for multiple indications and has benefited thousands of patients in China. The company is actively pursuing clinical trials worldwide and has published research results in prestigious medical journals, making it a promising candidate for SCLC treatment. HANSIZHUANG has also received orphan-drug designations from the U.S. FDA and the European Commission, with ongoing efforts for approvals in the European market. Additionally, a head-to-head trial comparing HANSIZHUANG with the standard of care Atezolizumab is underway in the United States, potentially advancing its approval in the U.S. market.

In the future, Henlius will continue to address unmet clinical needs and promote the global use of serplulimab to benefit more cancer patients.

This phase 3 clinical study is a randomized, double-blind, multi-center trial aiming to evaluate the effectiveness and safety of serplulimab in combination with chemotherapy and concurrent radiotherapy for patients with limited-stage small cell lung cancer (LS-SCLC). The primary goal is to assess overall survival (OS), with secondary endpoints including progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR), as well as safety and immunogenicity.

HANSIZHUANG, also known as serplulimab, is the first anti-PD-1 monoclonal antibody for the treatment of SCLC. It has received approvals for multiple indications in China and is undergoing review for marketing in the EU. Henlius is actively exploring its use in combination therapies for various cancer types through clinical trials around the world. HANSIZHUANG has been widely recommended in clinical practice guidelines and received orphan drug designations from regulatory bodies, emphasizing its potential in cancer treatment. Additionally, ongoing head-to-head trials in the United States aim to further establish its efficacy.



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