Shanghai, China, May 8th, 2023 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the latest clinical research data of four Henlius products, including the approved anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab), HLX07 (anti-EGFR mAb), HLX208 (BRAF V600E small molecule inhibitor), and HLX26 (anti-LAG-3 mAb), will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 2-6.
Notable among them is the updated analysis of ASTRUM-007 study, the pivotal phase 3 study of serplulimab in treating esophageal squamous cell carcinoma (ESCC) led 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. Previously, results from the interim analysis of ASTRUM-007 study was published in the international leading journal Nature Medicine (impact factor 87.241). Based on the results of ASTRUM-007 study, the new drug application (NDA) of serplulimab for the treatment of ESCC has been accepted by the National Medical Products Administration (NMPA).
Details of the ASCO-accepted abstracts are as follows:
1. HLX07-ESCC201
Title: A phase 2 study of HLX07 as monotherapy or combination therapy in patients with locally advanced, unresectable, or metastatic esophageal squamous cell carcinoma.
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
Form: Abstract and poster
Abstract ID: 4029
Time: The abstract will be released on May 25th, 2023, at 5:00 PM EDT on ASCO.org. The poster will be displayed on-site on June 5th, 2023, between 8:00 AM-11:00 AM CDT.
2. HLX208-LCH/ECD201
Title: A phase 2 study of HLX208, a BRAFV600E inhibitor, in adult patients with Langerhans cell histiocytosis and/or Erdheim-Chester disease harboring BRAFV600Emutation.
Leading PI: Jian Li, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Form: Abstract and poster
Abstract ID: 7574
Time: The abstract will be released on May 25th, 2023, at 5:00 PM EDT on ASCO.org. The poster will be displayed on-site on June 5th, 2023, between 8:00 AM-11:00 AM CDT.
3. HLX10-007-EC301
Title: Updated results of first-line serplulimab versus placebo plus chemotherapy in PD-L1–positive esophageal squamous cell carcinoma: A randomized, double-blind, multicenter phase 3 study (ASTRUM-007).
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
Form: Abstract
Abstract ID: e16016
Time: The abstract will be released on May 25th, 2023, at 5:00 PM EDT on ASCO.org.
4. HLX07-002
Title: Safety and tolerability of HLX07 combined with chemotherapy in patients with advanced solid tumors.
Leading PI: Jin Li, Shanghai East Hospital, School of Medicine, Tongji University
Form：Abstract
Abstract ID: e15001
Time: The abstract will be released on May 25th, 2023, at 5:00 PM EDT on ASCO.org.
5. HLX26-001
Title: Safety, tolerability, and pharmacokinetics of HLX26 (an anti-LAG3 antibody) in patients with advanced or metastatic solid tumors or lymphomas.
Leading PI: Jian Zhang, Fudan University Shanghai Cancer Center
Form: Abstract
Abstract ID: e14671
Time: The abstract will be released on May 25th, 2023, at 5:00 PM EDT on ASCO.org.
In the future, Henlius will keep focusing on patient needs and inspire more "made-by-Henlius" products with efficient and innovative in-house capabilities, aiming to provide highest quality solutions and services for patients worldwide.