From 2 to 4 December 2022, the European Society for Medical Oncology Asia (ESMO Asia) Congress will be held in Singapore. In this congress, Henlius’ two pivotal phase 3 clinical studies of anti-PD-1 mAb HANSIZHUANG (serplulimab) were selected for oral presentation. ASTRUM-005, the study of serplulimab as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC), will be presented by Professor Ying Cheng from Jilin Cancer Hospital and was selected as LBA (Late-breaking Abstract). ASTRUM-007, the study of serplulimab as first-line treatment in esophageal squamous cell carcinoma (ESCC), will be presented by Professor Jing Huang from National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College.
Details of the two studies are as follows:
·ES-SCLC
Title: Updated results of first-line serplulimab versus placebo combined with chemotherapy in extensive-stage small-cell lung cancer: an international multicentre phase 3 study (ASTRUM-005) (Abstract No.: LBA9)
Leading PI: Ying Cheng, Jilin Cancer Hospital
Categories: Oral presentation
Session: Proffered Paper session/Thoracic cancers
Presentation Time: 2 December 2022, 14:40 - 14:50 UTC+8
·ESCC
Title: First-line serplulimab versus placebo in combination with chemotherapy in PD-L1-positive oesophageal squamous cell carcinoma (ASTRUM-007): a randomised, double-blind, multicentre phase 3 study (Abstract No.: 69O)
Leading PI: Jing Huang, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Categories: Oral presentation
Session: Proffered Paper session/Gastrointestinal tumours
Presentation Time: 2 December 2022, 16:55 - 17:05 UTC+8
As the first innovative monoclonal antibody developed by Henlius, HANSIZHUANG has been approved by the National Medical Products Administration (NMPA) for the treatment of microsatellite instability-high (MSI-H) solid tumours and squamous non-small cell lung cancer (sqNSCLC), and the New Drug Applications (NDAs) of the first-line treatment for ES-SCLC and ESCC have been accepted by the NMPA. HANSIZHUANG covers a wide variety of indications and has been initiated 11 clinical studies on immuno-oncology combination therapies around the world, including many high-incidence cancers such as lung cancer, hepatocellular carcinoma, esophageal cancer, head and neck squamous cell carcinoma and gastric cancer. As of now, the company has enrolled more than 3,100 subjects worldwide and HANSIZHUANG is also an anti-PD-1 mAb with one of the largest global clinical data pools. Notably, HANSIZHUANG covers the full range of first-line treatment of lung cancer, including non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), among which the ES-SCLC study ASTRUM-005 has gained positive results, and HANSIZHUANG is the first anti-PD-1 mAb in the world gaining positive results in the first-line treatment of ES-SCLC. Its results were presented in oral at 2022 ASCO and were published in JAMA (impact factor: 157.3), one of the top medical journals in the world. HANSIZHUANG is potentially becoming the world’s first anti-PD-1 mAb for the first-line treatment of SCLC.