Pioneering PharmaceuticalSALK Antibodies and Opdivo Second-Line Treatment HCC Data Bright: Objective Remission Rate 40%

Poster Display Summary Title: Safety and efficacy of the configuration of 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) Abstract No.: 326 Prof. Xu Jun, M.D. (Hospital attached to Taiwan University School of Medicine) GT90001 is ALT-1 (Activin 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 virulability of GT90001 combined Nivolumab (O drug) in patients with advanced HCC who are progressing after the treatment of lavinib or lenfortinib.
this is a one-arm, open, two-stage clinical trial.
mainly observed the safety, tolerance and anti-tumor activity of the combination therapy.
phase 1 (safety assessment queue) grouped 6 subjects at gT90001 doses of 7mg/kg/kg per 2 weeks and Nivolumab 3mg/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. Dr. Tong Youyou, founder, chairman and CEO of
Pioneer Pharmaceuticals, said, "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 observe that GT90001 and Nivolumab's combination therapies are safe and effective, so that we will actively lay out multiple international multi-center Phase II/III clinical trials for advanced HCC treatments in China and the United States to benefit more patients.
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