The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting is set to take place from May 31 to June 4 in Chicago, the United States. Henlius will share the latest research data on its approved anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) during the conference.
At the 2024 ASCO, Henlius will release the extended follow-up results and patient-reported outcomes from the pivotal phase 3 clinical study (ASTRUM-005) of serplulimab for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) with Professor Ying Cheng from Jilin Cancer Hospital as the leading principal investigator. The results of ASTRUM-005 were first presented orally at the 2022 ASCO, and later published in the Journal of the American Medical Association (JAMA), one of the top four medical journals in the world. Thereafter, the updated results of ASTRUM-005 were released at the 2022 European Society for Medical Oncology Asia (ESMO Asia) Congress.
Additionally, the updated results of the phase 2/3 study (ASTRUM-015) of serplulimab in metastatic colorectal cancer (mCRC) will be released at the 2024 ASCO with Professor Rui-Hua Xu from Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer as the leading principal investigator. The results of this study were first presented at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI).
Details of the results to be presented at the 2024 ASCO are as follows:
1. ASTRUM-005
Title: Serplulimab vs. placebo combined with chemotherapy as first-line treatment for extensive-stage small-cell lung cancer: Extended follow-up results and patient-reported outcomes from the international phase 3 ASTRUM-005 study
Form: Abstract and poster
Session: Poster Session – Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Abstract Number: 8100
Leading PI: Ying Cheng, Jilin Cancer Hospital
Time: The abstract will be released on 2024/5/23, at 5:00 PM EDT on ASCO.org. The poster will be displayed on-site on 2024/6/3, 1:30 PM-4:30 PM CDT
2. ASTRUM-015
Title: First-line serplulimab plus HLX04 and XELOX versus placebo plus bevacizumab and XELOX in metastatic colorectal cancer: A phase 2/3 study
Form: Abstract and poster
Session: Poster Session – Gastrointestinal Cancer – Colorectal and Anal
Abstract Number: 3569
Leading PI: Rui-Hua Xu, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer
Time: The abstract will be released on 2024/5/23, at 5:00 PM EDT on ASCO.org. The poster will be displayed on-site on 2024/6/1, 1:30 PM-4:30 PM CDT
3. ASTRUM-005R
Title: Real-world first-line serplulimab-based immunochemotherapy for extensive-stage small cell lung cancer: The multicenter ASTRUM-005R study
Form: Abstract
Abstract Number: e20106
Authors: Lin Wu (Hunan Cancer Hospital), Chengping Hu (Xiangya Hospital, Central South University), et.al
Time: The abstract will be released on 2024/5/23, at 5:00 PM EDT on ASCO.org.
4. A retrospective study in LS-SCLC
Title: Neoadjuvant chemoimmunotherapy in patients with limited-stage small cell lung cancer: A retrospective study
Form: Abstract
Abstract Number: e20002
Authors: Qinghua Zhou, Lu Li, Ting Wang, Kaili Huang, et.al from West China Hospital, Sichuan University
Time: The abstract will be released on 2024/5/23, at 5:00 PM EDT on ASCO.org.
5. A randomised controlled, open-label, phase 2 trial in NSCLC
Title: Induction therapy with PD-1 antibody combined with platinum-based doublet chemotherapy for locally-advanced non-small cell lung cancer: A randomised controlled, open-label, phase 2 trial
Form: Abstract and poster
Abstract Number: 8044
Authors: Peng Zhang, Suyu Wang from Shanghai Pulmonary Hospital, School of Medicine, Tongji University
Time: The abstract will be released on 2024/5/23, at 5:00 PM EDT on ASCO.org. The poster will be displayed on-site on 2024/6/3, 1:30 PM-4:30 PM CDT
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 3,900 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.
