Shanghai, China, Oct 31st, 2023 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the phase 3 clinical study ASTRUM-002 of HANSIZHUANG (serplulimab injection), an innovative anti-PD-1 monoclonal antibody independently developed by the company, in combination with chemotherapy as a first-line treatment for patients with advanced non-squamous non-small cell lung cancer (nsNSCLC), met the primary endpoint of progression-free survival (PFS).
ASTRUM-002 is a three-arm, randomised, double-blind, multicentre phase 3 clinical study, aiming to compare the efficacy and safety of HANSIZHUANG combined with chemotherapy, HANSIZHUANG plus HANBEITAI combined with chemotherapy, or chemotherapy as a first-line treatment for patients with advanced nsNSCLC. The principal investigator of ASTRUM-002 is Professor Yuankai Shi from Cancer Hospital Chinese Academy of Medical Sciences. The primary endpoint is PFS assessed by independent radiological review committee (IRRC) per RECIST 1.1. Based on the results, HANSIZHUANG in combination with chemotherapy significantly prolonged PFS compared with placebo plus chemotherapy, which met the pre-specified efficacy criteria, with a manageable safety profile with no new safety signal identified.
According to GLOBOCAN data, lung cancer (LC) is the second commonly diagnosed cancer globally and accounts for 11.4% of the global cancer incidence in 2020[1]. It is estimated that there are 810,000 new cases with LC in China in 2020, and LC is the leading cause of cancer incidence and mortality[1-2]. About 85% of LC are NSCLC, of which sqNSCLC makes up about 25%, and the rest are nsNSCLC[3]. The advent of immune checkpoint inhibitors has been proved to bring hope to patients and anti-PD-1 mAb plus chemotherapy has been recommended by the latest NCCN guidelines and CSCO guidelines as the first-line treatment for nsNSCLC[4-5]. The ASTRUM-005 meeting the primary endpoint is expected to bring a new option for first-line treatment of nsNSCLC.
HANSIZHUANG is Henlius’ first self-developed innovative monoclonal antibody. Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. As of now, the company has enrolled over 3,600 subjects globally. Notably, HANSIZHUANG covers the full range of first-line treatment of lung cancer and over 90% of lung cancer patients are expected to benefit from the therapies. In the field of NSCLC, in addition to nsNSCLC, HANSIZHUANG has been approved for the treatment of squamous non-small cell lung cancer (sqNSCLC) in China. Besides, HANSIZHUANG has also been approved for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in China, making it the world's first anti-PD-1 mAb approved for the first-line treatment of SCLC, and its Marketing Authorization Application (MAA) for this indication has been validated by the European Medicines Agency (EMA) in March 2023, with approval expected in the first half of 2024. Henlius also launched a head-to-head bridging trial of HANSIZHUANG versus first-line standard-of-care atezolizumab for ES-SCLC in the U.S. to promote the submission of Biologics License Application (BLA) for HANSIZHUANG in the U.S. Previously, HANSIZHUANG was also granted orphan drug designations by the U.S. Food and Drug Administration (FDA) and European Commission (EC) for the treatment of SCLC. Furthermore, Henlius is steadily advancing a global phase 3 multi-center clinical research of HANSIZHUANG for the limited stage small cell lung cancer (LS-SCLC) and the first patients in China, the U.S., Europe, and Australia have been dosed, respectively.
In the future, Henlius will continue to invest in lung cancer, expand the indication layout in this field, and explore innovative combination treatments to improve patient outcome.
About HANSIZHUANG
HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC. Up to date, 3 indications are approved for marketing in China, 2 marketing applications are under review in China and the EU, and more than 10 clinical trials are ongoing across the world.
HANSIZHUANG was launched in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC). The marketing applications of the first-line treatment for esophageal squamous cell carcinoma (ESCC) and ES-SCLC are under review by the NMPA and the EMA, respectively. Focus on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 14 clinical trials on immuno-oncology combination therapies in a wide variety of indications. As of now, the company has enrolled more than 3,500 subjects in China, the U.S., Turkey, Poland, Georgia and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The results of 3 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA, IF: 157.3), Nature Medicine (IF: 87.241), and the British Journal of Cancer (IF: 9.075), respectively. Furthermore, HANSIZHUANG was respectively recommended for the first-line treatment of ES-SCLC in the 2022 CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer (SCLC) and the treatment of esophageal cancer (category IA) in the 2022 China Guidelines for Radiotherapy of Esophageal Cancer. Serplulimab was also granted orphan drug designations by the FDA and the EC for the treatment of SCLC, and the first patient has been dosed in a bridging head-to-head trial in the United States to comparing HANSIZHUANG to standard of care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC.