Shanghai, China, May 10th, 2021 –Shanghai Henlius Biotech, Inc. (2696.HK) announced that the two clinical studies results of Serplulimab Injection (HLX10, a recombinant humanised anti-PD-1 monoclonal antibody injection), independently developed by Henlius, will be presented at 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Currently, the New Drug Application (NDA) of Serplulimab for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) solid tumors that fail to respond to the standard therapy has been accepted and granted priority review by the National Medical Products Administration (NMPA). Serplulimab possesses the potential to be the first anti-PD-1 mAb in MSI-H solid tumours in China. ASCO Annual Meeting is one of the most influential and important oncology congresses all over the world, aimed to display the latest advances in clinical oncology researches and therapeutic technologies for tumour treatment. The 2021 ASCO Annual Meeting will be held online from June 4th to June 8th EDT.
Serplulimab Injection is an innovative anti-PD-1 mAb independently developed by Henlius. Up to now, Serplulimab have been approved for clinical trials in China, the United States, the European Union, as well as other countries and regions. A total of 10 immuo-oncology therapies clinical studies of Serplulimab have been conducted to evaluate its safety and efficacy in a variety of most common tumours that cover lung cancer, esophageal cancer, hepatocellular cancer, gastric cancer, head and neck cancer, etc. In March 2021, the pivotal Phase 2 study of Serplulimab in patients with unresectable or metastatic microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) solid tumours who have progressed on or been intolerant to standard therapies has met the primary endpoint, demonstrating the good efficacy and safety of Serplulimab.
Details of two studies are as follows:
1. HLX10-MSI201
Title: Efficacy and safety of HLX10, a novel anti-PD-1 antibody, in patients with previously treated unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumors: a single-arm, multicentre, phase 2 study
Co-Leading PI:Shukui Qin, MD, PhD, Chinese People's Liberation Army Cancer Center of Nanjing Bayi Hospital; Jin Li, MD, PhD, Shanghai East Hospital
Form: Abstract and Poster
Abstract No.:2566
Time: The abstract will be released on May 19th, 2021, at 5:00 PM EDT on ASCO.org., the detailed results of this study will be presented during the Meeting (from June 4th to June 8th EDT) in a poster
This single-arm, open-label, multicentre, phase 2 study aimed to evaluate the efficacy, safety, and tolerability of Serplulimab Injection in patients with unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumours who have progressed on or been intolerant to standard therapies. The primary efficacy endpoint was objective response rate (ORR) assessed by independent radiological review committee (IRRC) per RECIST v1.1. Secondary endpoints included ORR assessed by investigators, duration of response (DoR), progression-free survival (PFS), overall survival (OS), safety and tolerability. The results demonstrate that Serplulimab Injection, as a tissue-agnostic cancer drug, provides encouraging antitumour activity with a manageable safety profile in patients.
2. HLX10-CC201
Title:Efficacy and safety evaluation of HLX10 (a recombinant humanised anti-PD-1 monoclonal antibody) combined with albumin-bound paclitaxel in patients with advanced cervical cancer who have progressive disease or intolerable toxicity after first-line standard chemotherapy: a single-arm, open-label, phase 2 study
Leading PI: Lingying Wu, MD, PhD, Cancer Hospital Chinese Academy of Medical Sciences
Form: Abstract
Abstract No.: e17510
Time: On May 19th, 2021, at 5:00 PM EDT on ASCO.org.
This is a single-arm, open-label, multicentre, phase 2 study, primarily aimed to evaluate the clinical efficacy of HLX10 in combination with albumin-bound paclitaxel for the treatment of advanced cervical cancer patients who have failed to respond to the first-line standard chemotherapy. Secondary objectives include the safety and tolerability evaluations of HLX10 in combination with albumin-bound paclitaxel in the relevant patient group and correlations evaluation between the biomarkers (PD-L1, MSI1 and TMB2) and the efficacy.
Notes:
1. MSI, microsatellite instability (微卫星不稳定型)
2. TMB, tumour mutational burden (肿瘤突变负荷)