On December 9, Pioneer Pharmaceuticals announced that it will publish positive data from the APK-1 Antibody GT90001 Joint PD-1 Antibody Nivolumab Second-Line Treatment of Advanced Hepatocellular Carcinoma (HCC) Patient Phase II Trials at the 2021 American Society of Clinical Oncology (ASCO GI) Gastrointestinal Oncology Symposium (ASCO GI).
results show that the efficacy of combination therapy is encouraging and safe.
2021 ASCO GI will be held from January 15-17, 2021 local time.
poster display summary title: Safety and efficacy of the configuration of the GT90001, an anti-activin receptor-like kinase-1 (ALK-1) antibody, And nivolumab in patients with metastatic hepatocellular carcinoma (HCC) ALK-1 antibody (GT90001) combined with PD-1 antibody (Nivolumab) to treat advanced hepatocellular carcinoma (HCC) safety and effective summary number: 326 First Professor Xu Jun, M.D. (Hospital attached to Taiwan University School of Medicine) GT90001 is ALTin Receptor-Like Kinase-1, activator receptor-like kinase-1) all-human monoclonal antibody, Pioneer Pharmaceuticals will receive the exclusive rights to develop, produce and commercialize the drug worldwide from Pfizer in 2018.
ALK-1 antibody can inhibit tumor blood vessel growth, reduce blood flow and angiogenesty by blocking the APK-1 subject path path, thereby slowing tumor growth and changing tumor micro-environment.
GT90001 as a potential global first-in-class innovative drug, is expected to be used in the treatment of a variety of solid tumors.
Pioneer Pharmaceuticals launched the GT90001 Joint Nivolumab (PD-1 Antibody) phase II clinical trial for the treatment of advanced liver cancer in Taiwan on May 7, 2019 to assess the safety and effective of GT90001 combined Nivolumab (O-drug) in patients with advanced HCC who progressed after the treatment of laphine or lenvatinib.
this is a one-arm, open, two-stage clinical trial.
mainly observed the safety, tolerance and anti-tumor activity of combination therapy.
phase 1 (safety assessment queue) grouped 6 subjects at a dose of GT90001 of 7 mg/kg per 2 weeks and Nivolumab of 3 mg/kg per 2 weeks.
14 subjects in the second stage (extended queue) group were treated with the same dose.
, according to RECIST v1.1, subjects were treated until they lost clinical efficacy or developed insatiable toxicity, with the main endpoint of efficacy being the objective mitigation rate (ORR) assessed by the researchers.
results showed that between 9 July 2019 and 30 September 2020, 8 out of 20 assessable patients observed partial remission (PR), with an objective remission rate of 40% and good safety.
pharmacodynamic parameters of GT90001 and Nivolumab are similar to 10-drug therapy. "With the global rights to GT90001, the company has adjusted its clinical development strategy in a timely manner and adopted a clinical approach in combination with immunotherapy, and we are pleased to see that GT90001 and Nivolumab's combination therapies are safe and effective, so that we will actively conduct multiple international multi-center Phase II/III clinical trials in China and the United States to benefit more patients with advanced HCC treatments," said Dr. Tong You, founder, chairman and CEO of
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