Shanghai, China, March 7th, 2024 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the exploratory biomarker analysis of ASTRUM-005, Henlius’ phase 3 clinical study of its innovative anti-PD-1 mAb HANSIZHUANG (serplulimab) as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC) will be released at the American Association for Cancer Research 2024 meeting (AACR 2024), which will take place in San Diego, United States from April 5-10.The AACR is the oldest and largest scientific organization in the world focused on every aspect of high-quality, innovative cancer research.
HANSIZHUANG (serplulimab) is the company’s first innovative product, as well as the world's first anti-PD-1 mAb for the first-line treatment of SCLC. Since its first approved in China in March 2022, HANSIZHUANG has been approved for 4 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, and esophageal squamous cell carcinoma (ESCC), benefiting more than 55,000 patients. The marketing applications of the first-line treatment for non-squamous non-small cell lung cancer (nsNSCLC) and ES-SCLC are under review by the NMPA and the European Medicines Agency (EMA), respectively.
ASTRUM-005 (NCT04063163), the pivotal clinical trial of serplulimab is a randomised, double-blind, international, multicentre, phase 3 study aimed to compare the efficacy and safety of serplulimab, versus placebo in combination with chemotherapy in previously untreated ES-SCLC patients. The results of ASTRUM-005 were first presented at 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, and published in The Journal of the American Medical Association (JAMA), one of the top four medical journals in the world in September 2022. Thereafter, the updated results of ASTRUM-005 were released at the 2022 European Society for Medical Oncology Asia (ESMO Asia) Congress.
To elaborate biological characteristics of the ES-SCLC patients who has benefited from serplulimab in this study, Henlius completed an exploratory biomarker analysis to retrospectively evaluate the association of proteome signature, genetic mutations, and hematological indices with the efficacy of serplulimab.
Details of the abstract are as follows:
Title: Exploratory biomarker analysis of phase 3 ASTRUM-005 study: Serplulimab versus placebo plus chemotherapy for extensive-stage small cell lung cancer
Session Title: predictive biomarkers 5
Leading PI: Professor Ying Cheng, Jilin Cancer Hospital
Session Type: Poster Session
Abstract Number: 6390
Date and Time: April 9, 2024, 1:30 PM -5:00 PM PDT/ April 10, 2024, 4:30 AM - 8:00 AM CST
Location: Poster Section 43, Board #2
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 and has been approved in China and Indonesia. Up to date, 4 indications are approved for marketing, 2 marketing applications are under review in China and the EU, and more than 10 clinical trials are ongoing across the world.
HANSIZHUANG was approved in China in March 2022 and has been approved by the National Medicinal Products Administration (NMPA) for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). The marketing applications of the first-line treatment for non-squamous non-small cell lung cancer (nsNSCLC) and ES-SCLC are under review by the NMPA and the European Medicines Agency (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. The company has initiated more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications with more than 3,700 subjects enrolled in China, the U.S., Turkey, Poland, Georgia and other countries and regions. The results of 4 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell and the British Journal of Cancer, respectively. Furthermore, HANSIZHUANG was respectively 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 tumours. On the other hand, serplulimab was granted orphan drug designations by the U.S. FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.
注：本文设计图片均来自AACR大会官网https://www.aacr.org/meeting/aacr-annual-meeting-2024