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Kintor‘s GT90001 and Nivolumab Combination Therapy Obtains Approval of Phase II Clinical Trial from US FDA for the Second-Line Treatment of Advanced Hepatocellular Carcinoma

Kintor‘s GT90001 and Nivolumab Combination Therapy Obtains Approval of Phase II Clinical Trial from US FDA for the Second-Line Treatment of Advanced Hepatocellular Carcinoma

(Summary description)Suzhou, Feb.18, 2021--Kintor Pharmaceutical Limited (HKEX:9939) is pleased to announce that the investigational new drug ("IND") application of GT90001 for a multi-regional phase II clinical trial for combination treatment of GT90001 and Nivolumab (Opdivo®) for the second-line treatment of advanced hepatocellular carcinoma (“HCC”) was approved by the Food and Drug Administration (the "US FDA") on February 11, 2021.

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  • Time of issue:2021-02-18 13:51
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Suzhou, Feb.18, 2021--Kintor Pharmaceutical Limited (HKEX:9939) is pleased to announce that the investigational new drug ("IND") application of GT90001 for a multi-regional phase II clinical trial for combination treatment of GT90001 and Nivolumab (Opdivo®) for the second-line treatment of advanced hepatocellular carcinoma (“HCC”) was approved by the Food and Drug Administration (the "US FDA") on February 11, 2021.

 

Dr. Tong Youzhi, the Founder, Chairman and CEO of Kintor Pharma, commented, "After the combination treatment of Atezolizumab plus Bevacizumab was approved in the US in May 2020, it has become the first-line treatment for advanced HCC in the US and is being gradually adopted by other countries. However, the second-line treatment for advanced HCC is still unclear, which presents a challenge to Kintor in selecting clinical trial strategy. After communication with the US FDA, we were approved to adopt the two-cohort parallel approach to explore the second-line treatment for advanced HCC. The purpose of such accelerated clinical study approach is to seek conditional new drug approval with data from the multi-regional phase II clinical trial or proceed with a phase III clinical trial with an expanded cohort."

 

GT90001 is a fully human IgG2 neutralizing monoclonal antibody that inhibits ALK-1/TGF-β signal transduction and tumor angiogenesis. The phase II clinical trial started on May 7, 2019 in Taiwan (“Taiwan phase II clinical trial”) , evaluated the efficacy and safety of GT90001 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%. For more details, please refer to "Kintor Presented Results of GT90001 and Opdivo at ASCO GI 2021".

 

The phase II clinical trial approved by the FDA is two-cohort parallel, randomized, open label study to evaluate the efficacy and safety of GT90001 in combination with Nivolumab in patients with advanced HCC who had progressed after or intolerant to first-line treatment. Cohort A of the phase II clinical trial will include patients who received tyrosinekinase inhibitor (TKI) as first-line systemic treatment, such as Sorafenib or Lenvatinib. Cohort B of the phase II clinical trial will enroll patients who received immune checkpoint inhibitors (ICI) as their first line systemic treatment, such as Atezolizumab plus Bevacizumab. Approximately 350 patients will be enrolled in the study. The primary endpoint is to assess the ORR as evaluated by an IRC according to RECISTv1.1.

 

Kintor Pharmaceuticals obtained an exclusive global license for all oncological applications for GT9001 from Pfizer, Inc., in February 2018.

 

Opdivo® is a registered trademark of Bristol Myers Squibb.

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