From 6 to 8 December 2024, the European Society for Medical Oncology Asia (ESMO Asia) Congress will be held in Singapore. At this congress, Henlius will share the latest results of clinical trials of several products, including HANSIZHUANG (serplulimab), HLX07 (anti-EGFR mAb), and daratumumab biosimilar HLX15.
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 SCLC. It has been approved in China and multiple countries in Southeastern Asia. Underpinned by the patient-centric strategy, Henlius has carried out a differentiated and multi-dimensional layout in the field of gastrointestinal cancer and lung cancer, covering a wide variety of indications. Up to date, HANSIZHUANG has been approved by the National Medical Products Administration (NMPA) for the treatment of 4 indications, benefiting more than 85,000 patients. Moreover, a wide variety of clinical trials on immuno-oncology combination therapies in differentiated indications has been initiated by the company to further explore the efficacy of the product, such as HANSIZHUANG plus bevacizumab and chemotherapy as first-line treatment for patients with metastatic colorectal cancer (mCRC), HANSIZHUANG plus chemotherapy as neoadjuvant/adjuvant therapy for gastric cancer (GC), and HANSIZHUANG plus chemotherapy and concurrent radiotherapy in patients with limited-stage small cell lung cancer (LS-SCLC), etc.
HLX07 is an innovative drug targeting EGFR independently developed by Henlius. Adopting the self-developed advanced antibody engineering platform, Henlius re-engineered cetuximab by humanising its Fab regions and minimizing its glycan contents to generate HLX07 to reduce immunogenicity and maintain a high binding affinity of the product. Currently, Henlius is conducting phase 2 clinical trials to explore HLX07 as monotherapy or in combination with HANSIZHUANG (serplulimab) for the treatment of solid tumours including esophageal squamous cell carcinoma (ESCC), cutaneous squamous cell carcinoma (CSCC), and nasopharyngeal carcinoma (NPC).
HLX15 is a fully human anti-CD38 IgG1κ monoclonal antibody independently developed by Henlius. The indication to be developed for HLX15 is multiple myeloma (MM). In accordance with the biosimilar guidelines of NMPA, EMA, and FDA, HLX15 has been developed strictly following the principles of stepwise development, comparability and similarity assessment and has been compared head-to-head with reference daratumumab via analytical studies and preclinical studies. In June 2024, the phase 1 clinical trial of HLX15 met its primary endpoint.
Results to be presented at the ESMO Asia 2024 are as follows:
ASTRUM-004R Study
Title: First-Line Serplulimab for Advanced Squamous Non-Small Cell Lung Cancer: A Multicenter, Single-Arm, Real-World ASTRUM-004R Study
Presentation Number: 682P
Speaker: Bo Shen, Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital, Nanjing Medical University
Time: December 7, 2024, 17:50-18:45 PM SGT
Session: Mini Oral session: Genitourinary tumours
Title: Efficacy and safety of fruquintinib combined with serplulimab as 1st line treatment in advanced non-clear cell renal cell carcinoma (nccRCC): A single-arm, multicentre clinical trial
Presentation Number: 274MO
Speaker: Jiwei Huang, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Time: December 8, 2024, 9:42 – 9:47 AM SGT
HLX07-NPC
Session: Mini Oral session: Head and neck cancers
Title: First-line HLX07 vs. Placebo Combined with Serplulimab and Chemotherapy for Nasopharyngeal Cancer: a Randomised, Double-blind, Multicentre Phase 2 study
Presentation Number: LBA3
Leading PI: Li Zhang, Sun Yat-sen University Cancer Center
Time: December 7, 2024, 14:40-14:45 PM SGT
HLX07-CSCC
Title: Efficacy and Safety of HLX07 Monotherapy in Advanced Cutaneous Squamous Cell Carcinoma: an Open-label, Multicentre Phase 2 Study
Presentation Number: 759P
Leading PI: Changxin Li, Southern Medical University Nanfang Hospital
Time: December 7, 2024, 17:50-18:45 PM SGT
HLX15-001
Title: A Randomised, Double-blind, Phase I Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of HLX15 and Daratumumab in Healthy Male Participants
Presentation Number: 63P
Leading PI: Yu-wen Su, Sir Run Run Hospital, Nanjing Medical University
Time: December 7, 2024, 17:50-18:45 PM SGT