2024 World Conference on Lung Cancer (“WCLC 2024”) will be held from September 7-10 in San Diego, United States. Multiple updated results of Henlius’ self-developed innovative anti-PD-1 mAb, HANSIZHUANG (serplulimab), will be released as poster presentations at the meeting.
HANSIZHUANG (serplulimab) is a recombinant humanised anti-PD-1 monoclonal antibody（mAb）injection independently developed by Henlius, and the world's first anti-PD-1 mAb approved for the first-line treatment of small cell lung cance(SCLC). Underpinned by clinical needs, Henlius has carried out a differentiated and multi-dimensional layout of HANSIZHUANG in the field of lung cancer and gastrointestinal cancer. Up to date, it has been approved by the National Medical 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), benefitting over 75,000 patients.
Lung cancer is one of the most common malignancies around the world. According to GLOBOCAN, there were 2.5 million new lung cancer cases in 2022 worldwide[1]. Henlius has successively conducted a number of immuno-combination therapy clinical trials with serplulimab, including several global multi-centre phase 3 clinical trials regarding sqNSCLC, ES-SCLC and limited-stage small cell lung cancer (LS-SCLC), covering the full range of first-line treatments of lung cancer. Moreover, Henlius has initiated a head-to-head bridging 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.
Updated results to be presented at the 2024 WCLC conference are as follows:
ASTRUM-005 Study
Presentation Number: P1.13A.07.
Title: Real-World First-Line Serplulimab-Based Immunochemotherapy for Extensive-Stage Small Cell Lung Cancer: The Multicenter ASTRUM-005R Study
Leading PI: Lin Wu (Hunan Cancer Hospital), Chengping Hu (Xiangya Hospital, Central South University)
Time: Sunday, September 8, 2024 at 12:00 PM PDT/ UTC -7
A retrospective study
Presentation Number: EP.13C.04.
Title: Is Neoadjuvant Chemoimmunotherapy Better Than Chemotherapy in Patients with Limited-Stage Small Cell Lung Cancer
Leading PI: Qinghua Zhou (West China Hospital, Sichuan University)
Time: Saturday, September 7, 2024 at 11:58 AM PDT/ UTC -7
A prospective study
Presentation Number: EP.13C.03.
Title: Investigating Surgery's Role in Stage IIB-IIIB Small Cell Lung Cancer Following Chemo-immunotherapy
Leading PI: Wenzhao Zhong (Guangdong Provincial People’s Hospital)
Time: Saturday, September 7, 2024 at 11:58 AM PDT/ UTC -7
Reference
[1] International Agency for Research on Cancer. Global Cancer Observatory: Cancer Today [DB/OL]. http://gco.iarc.who.int/today [2024-02-01]
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. Focusing 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 4,000 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 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.