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Henlius’ Second U.S. Clinical Investigators Meeting: In-Depth Exploration of Small Cell Lung Cancer Treatment Innovations


Recently, Henlius’ second U.S. clinical investigators meeting was held in New Orleans, LA. Over 100 investigators from more than 70 clinical sites in the United States (U.S.) gathered to discuss the latest research results and application prospects of HANSIZHUANG (serplulimab) in small cell lung cancer treatment. Currently, Henlius is actively advancing two pivotal clinical trials in the U.S. for the first-line treatment of small cell lung cancer (SCLC) with HANSIZHUANG, ASTRIDE study, a head-to-head bridging trial of HANSIZHUANG versus the standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of extensive-stage SCLC (ES-SCLC), and ASTRUM-020, an international multicentre Phase 3 clinical trial of HANSIZHUANG in combination with chemotherapy and concurrent radiotherapy for the first-line treatment of limit-stage SCLC (LS-SCLC).

Dr. Jianjun Zhang, Assistant Professor in the Department of Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center, remarked, “We are delighted to be part of this trial. I believe the trial design strikes an excellent balance between scientific rigor and practicality. I am eagerly anticipating the results and the potential global impact of this innovative treatment.”

Dr. Feldman Lawrence, Professor of Clinical Medicine at College of Medicine, University of Illinois, stated, “It was a fantastic meeting, and it generated a great deal of interest and enthusiasm for these trials. More than ever I am anxious to get them open at our site and started enrolling patients”


“The treatment of SCLC used to be a worldwide challenge, and HANSIZHUANG, as the world's first and currently the only anti-PD-1 mAb approved in the field of SCLC, has already benefited many Chinese ES-SCLC patients,” stated Jason Zhu, Executive Director, Chief Executive Officer and Chief Financial Officer of Henlius. “We have been working with our partners to promote the launch of HANSIZHUNG in ES-SCLC in the EU and Southeast Asia, and its Marketing Authorization Application (MAA) has been validated by the European Medicines Agency (EMA) and is expected to be approved in the first half of 2024. Now, Henlius' ASTRIDE and ASTRUM-020 studies in the U.S. are precisely intended to further challenge and overcome this challenge to benefit more patients.”

According to GLOBOCAN 2020, lung cancer (LC) is the first mortality cancer around the world [1]. SCLC accounts for 15% of the total number of LC [2] and is divided into two stages, LS-SCLC and ES-SCLC, and 30%–40% patients are in LS-SCLC at the time of diagnosis [3]. The standard treatment regimens for LS-SCLC are 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 [4–6]. Overall, SCLC is featured by high malignancy, strong invasiveness, early metastasis, and rapid disease progression, with extremely poor prognosis. The advent of immune checkpoint inhibitors has been proven to bring hope to patients with ES-SCLC but has not yet shown benefit in those with LS-SCLC. At present, PD-1/L1 inhibitors such as serplulimab (HANSIZHUANG) in combination with chemotherapy have been recommended by the 2022 CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer for the treatment of ES-SCLC, and anti-PD-L1 monoclonal antibodies in combination with chemotherapy have been recommended as the first-line treatment for ES-SCLC by NCCN Guidelines.


ASTRUM-005, the international multi-centre, phase 3 study in patients with ES-SCLC, has been published in The Journal of the American Medical Association (JAMA), making ASTRUM-005 became the first study published in JAMA on SCLC immunotherapy. In 2022, the United States Food and Drug Administration (FDA) granted orphan drug designation to HANSIZHUANG for treatment of SCLC, which is beneficial for the continuous development of HANSIZHUANG and the enjoyment of certain policy support in terms of registration and commercialization in the U.S. Meanwhile, based on the positive feedback of FDA Biologics license Application (BLA) submission for HANSIZHUANG for the treatment of ES-SCLC and the discussion results of the FDA's Class C consultation meeting, Henlius has initiated ASTRIDE study in the U.S. and plans to recruit 100 pairs of U.S. patients with ES-SCLC to evaluate the efficacy of HANSIZHUANG. In addition, the company also actively carries out exploration around LS-SCLC, aiming to cover the first-line treatment of SCLC. Up to date, the first subjects in China, the U.S., Europe, Australia and other countries and regions have been dosed for ASTRUM-020.


The meeting not only served as a great opportunity to showcase Henlius’ technical strength and innovation in oncology and SCLC, but also a forum for in-depth discussions and exchanges between the investigators of ASTRIDE and ASTRUM-020, focusing on the latest research progress and therapeutic innovations in the field of SCLC. Meanwhile, the attendees shared their experiences in conducting the two studies and insights for the rapid and high-quality advancement of subsequent developments. Henlius will continue to promote the two clinical studies to accelerate the global launch of HANSIZHUANG and provide more effective treatment options for more SCLC patients around the world.


[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]Eskandar A, Ahmed A, Daughtey M, et al. Racial and sex differences in presentation and outcomes of small cell lung cancer in the United States: 1973 to 2010[J].Chest, 2015,147(4): e164-e165.

[3]Klautke G , Sauer R, Fietkau R .Combined Treatment Modality in Small Cell Lung Cancer[J]. Strahlentherapie Und Onkologie, 2008, 184(2):61-66.

[4] 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.

[5] 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.

[6] 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.