Recently, the clinical investigators meeting for ASTRIDE, the head-to-head bridging trial of HANSIZHUANG (serplulimab), was held in Nashville, TN. 34 investigators from 63 clinical sites in the United States gathered to discuss the latest research results and application prospects of HANSIZHUANG in tumour treatment, and reviewed the safety and effectiveness data from a previous clinical study on HANSIZHUANG in ES-SCLC, focusing on in-depth discussions on the research protocols and implementation strategies of head-to-head clinical trials being conducted in the United States.
"While there have been recent advances in the treatment of extensive stage small cell lung cancer, there is a continuing need to optimize the therapeutic approach. I am pleased to be a principal investigator for the ASTRIDE study, which is pursuing this goal," said David Gandara, M.D., Professor Emeritus and Co-director of the Center for Experimental Therapeutics at the University of California Davis Comprehensive Cancer Centre. “The promising Phase 3 results from the previous ASTRUM-005 reported in JAMA provide the foundation for moving forward with evaluation of serplulimab in the USA. I will be working with the Henlius team to promote completion of ASTRIDE, hopefully leading to availability of serplulimab in this country."
"Serplulimab is the world's first anti-PD-1 monoclonal antibody approved for ES-SCLC, and it has benefited over 13,000 Chinese small cell lung cancer patients," stated Jason Zhu, President and Chief Financial Officer of Henlius. “It is an honour for us to welcome professionals to discuss and make recommendations on the ASTRIDE bridging research. Insights gained from this meeting, I believe, will build a solid foundation for the ASTRIDE bridging study, and drive more progress towards its goals. I look forward to working with all of the investigators and benefiting more patients with small cell lung cancer all across the world."
Based on the positive feedback from the US Food and Drug Administration (FDA) Biologics License Application (BLA) submission for HANSIZHUANG for the treatment of ES-SCLC and the discussion on the FDA's Type C consultation meeting, Henlius has carried out a bridging head-to-head trial, ASTRIDE, in the United States comparing HANSIZHUANG (serplulimab) to the standard of care Atezolizumab (anti-PD-L1 mAb) and plans to recruit 100 pairs of US patients with ES-SCLC to evaluate the efficacy of HANSIZHUANG. In November 2022, the first patient was dosed in ASTRIDE and the company plans to submit BLA to FDA in 2024.
Previously, Henlius has conducted ASTRUM-005, an international multi-centre phase 3 study of HANSIZHUANG plus chemotherapy as a first-line treatment for patients with ES-SCLC. ASTRUM-005 has set up a total of 128 sites in various countries including China, Turkey, Poland, and Georgia, and enrolled 585 subjects who were screened from 114 sites, among whom 31.5% were White. As of the data cut-off date (June 13, 2022), median overall survival (OS) was significantly longer in the serplulimab group (15.8 months) than in the placebo group (11.1 months), setting a record. In addition, the study showed good safety and consistent efficacy over time. The results of ASTRUM-005 were presented for the first time in an oral report at the 2022 ASCO annual meeting, and ASTRUM-005 went on to become the first immunotherapy clinical study of SCLC to be published in The Journal of the American Medical Association (JAMA, impact factor of 157.3), one of the top four medical journals in the world. Based on the results from ASTRUM-005, HANSIZHUANG was granted Orphan Drug Designations by the FDA and the European Commission (EC) for the treatment of SCLC, benefiting the continuous development of HANSIZHUANG and the enjoyment of certain policy support in terms of registration and commercialization in the markets respectively. Recently, the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for HANSIZHUANG for the first-line treatment of ES-SCLC.
The holding of the ASTRIDE Clinical Investigators Meeting in the United States further proved the company's technical strength and innovative ability in anti-tumour research and clinical development. The company will keep investing in HANSIZHUANG's global clinical research, accelerate its global market access process, and offer more and more effective treatment options to patients.
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 theJournal of the American Medical Association (JAMA, IF: 157.3), Nature Medicine (IF: 87.241), and the British Journal of Cancer (IF: 9.075), respectively. On the other hand, HANSIZHUANG was recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Guidelines for Colorectal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumors. Furthermore, Serplulimab was 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.