Kintor Pharmaceutical Limited Announces China NMPA Approves Clinical Trial of ALK-1 and Nivolumab Combination Therapy for the First-line Treatment of Advanced Hepatocellular Carcinoma
October 11, 2021 at 01:00 am EDT
Kintor Pharmaceutical Limited announced that the clinical trial of ALK-1 antibody (GT90001C) and Nivolumab (Opdivo®) combination therapy for the treatment of systemic therapy naïve patients with advanced hepatocellular carcinoma ("HCC") was approved by the National Medical Products Administration (the "NMPA") of China on October 9, 2021. ALK-1 antibody is a fully human IgG2 neutralizing monoclonal antibody that inhibits ALK-1/TGF-ß signal transduction and tumor angiogenesis. Kintor Pharma obtained an exclusive global license for all oncological applications for ALK-1 antibody from Pfizer Inc., in February 2018. The phase II clinical trial of the combination therapy of ALK-1 antibody and Nivolumab on patients with advanced HCC has started on May 7, 2019 in Taiwan, China ("Taiwan phase II clinical trial"), evaluated the efficacy and safety of ALK-1 antibody in combination with Nivolumab in patients with advanced HCC who were progressed on or intolerant to first-line therapy with Sorafenib or Lenvatinib. The preliminary data of the ongoing Taiwan phase II clinical trial was released at the ASCO GI 2021 (held between January 15 – 17, 2021), and showed positive efficacy and safety results. The overall response rate ("ORR") was 40%. On 11 February 2021, the investigational new drug application of multiregional phase II clinical trial of combination therapy of ALK-1 antibody and Nivolumab for the second-line treatment of advanced HCC was greenlighted by the United States Food and Drug Administration.