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Henlius Anti-PD-1 mAb Serplulimab IND for MRCT Phase 3 Studies on First-Line LS-SCLC Patients Approved by NMPA

2022-03-31


Shanghai, China, March 31st, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug application (IND) of international multicenter phase 3 studies of HANSIZHUANG (serplulimab), an innovative anti-PD-1 monoclonal antibody (mAb) independently developed by the Company, in combination with chemotherapy and concurrent radiotherapy in patients with limited-stage small cell lung cancer (LS-SCLC) has been approved by the National Medical Products Administration (NMPA). Previously, the global multi-center phase 3 study of HANSIZHUANG for the first-line treatment of extensive stage small-cell lung cancer (ES-SCLC) has met the primary study endpoint of the overall survival (OS), and its NDA in China and MAA in the EU are expected to be filed in 2022, making HANSIZHUANG potentially the world’s first PD-1 inhibitor for the first-line treatment of SCLC.


According to GLOBOCAN 2020, lung cancer (LC) is the second commonly diagnosed and the first mortality cancer around the world. There were 2.2 million new LC cases and 1.8 million new deaths in 2020 worldwide, and LC is still the leading cause of cancer deaths[1]. SCLC accounts for 15%–20% of the total number of LC, whcih is featured by high malignancy, strong invasiveness, early metastasis, and rapid disease progression, with extremely poor prognosis. LC is divided into two stages, including limited stage and extensive stage, and 30%40% patients are in limited stage at the time of diagnosis. The standard treatment regimens for LS-SCLC is surgery, chemotherapy and concurrent radiotherapy. Traditional chemotherapeutic drugs did not exhibit significant progress in patients with LS-SCLC, and most patients tend to develop drug resistance or rapid relapse[24]. The advent of immune checkpoint inhibitors has been proved to bring hope to patients with ES-SCLC, but has not yet to show benefit in those with LS-SCLC. The company 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 tumors. With HANSIZHUANG as the backbone, Henlius conducts and accelerates various clinical trials with immuno-oncology combination therapies worldwide in a wide variety of high-incidence solid tumors, including LC, esophageal carcinoma, head and neck carcinoma, gastric cancer, etc., and covering the full range of first-line treatments of LC. Up to date, more than 2,800 subjects have been enrolled worldwide for HANSIZHUANG clinical trials, which makes it a PD-1 inhibitor with one of the largest global clinical data pools and lays a solid foundation for future applications across the world. Notably, two global multi-center phase 3 clinical trials regarding squamous non-small cell lung cancer (sqNSCLC) and ES-SCLC have been conducted in China, Turkey, Poland, Georgia and other countries and regions, with Caucasians accounting for over 30% of the total enrolled subjects, providing more diverse cases for clinical research. The NDA of the treatment for locally advanced or metastatic sqNSCLC has been accepted by the NMPA and is expected to be approved in 2022.


In the future, the company will continue to emphasize unmet clinical needs and actively promote the combination immunotherapy of serplulimab and international regulatory registration to benefit more patients around the world.


Reference

[1] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249.

[2] Faivre-Finn C, Snee M, Ashcroft L, Appel W, Barlesi F, Bhatnagar A, Bezjak A, Cardenal F, Fournel P, Harden S, Le Pechoux C, McMenemin R, Mohammed N, O'Brien M, Pantarotto J, Surmont V, Van Meerbeeck JP, Woll PJ, Lorigan P, Blackhall F; CONVERT Study Team. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. Lancet Oncol. 2017 Aug;18(8):1116-1125.

[3] Wang Z, Wan J, Liu C, Li L, Dong X, Geng H. Sequential Versus Concurrent Thoracic Radiotherapy in Combination With Cisplatin and Etoposide for N3 Limited-Stage Small-Cell Lung Cancer. Cancer Control. 2020 Jan-Dec;27(1):1073274820956619.

[4] Ha IB, Jeong BK, Jeong H, Choi HS, Chai GY, Kang MH, Kim HG, Lee GW, Na JB, Kang KM. Effect of early chemoradiotherapy in patients with limited stage small cell lung cancer. Radiat Oncol J. 2013 Dec;31(4):185-90.