Kintor Pharmaceutical Announces FDA Approval of Phase II Global Clinical Trial for GT90001 in Combination with Nivolumab for Second-Line Treatment of Advanced Hepatocellular Carcinoma

Suzhou, Feb. 18, 2021 /PRNewswire/ -- On February 18, 2021, Kintor Pharmaceutical Limited (Stock Code: 9939.HK, hereinafter referred to as “Kintor”) announced that its Investigational New Drug (IND) application for the Phase II clinical trial (a global multi-center clinical trial, MRCT) of GT90001, an ALK-1 antibody, in combination with Bristol-Myers Squibb’s (BMS) PD-1 monoclonal antibody Nivolumab (Opdivo) for the second-line treatment of advanced hepatocellular carcinoma (HCC), has been approved by the U.S. Food and Drug Administration (FDA).

GT90001 is a fully human IgG.₂Neutralizing antibodies can inhibit ALK-1/TGF-β signal transduction and tumor angiogenesis. The Phase II clinical trial of GT90001 in combination with Nivolumab for patients with advanced HCC who progressed after first-line sorafenib or lenvatinib treatment was initially conducted in Taiwan, China. Previously, clinical trial data from Taiwan presented at ASCO GI 2021 showed that the combination therapy demonstrated encouraging efficacy and a favorable safety profile, with an objective response rate (ORR) of 40%. (For detailed information, please refer to the news article “Kintor’s GT90001 in Combination with Nivolumab for the Treatment of Advanced Hepatocellular Carcinoma: Phase II Clinical Study Presented at ASCO GI 2021”）

This FDA-approved Phase II clinical trial is a randomized, open-label, parallel-group study designed to evaluate the efficacy and safety of GT90001 in combination with nivolumab for the treatment of patients with advanced hepatocellular carcinoma (HCC) who have progressed after or are intolerant to first-line therapy. The trial is expected to enroll approximately 350 subjects, stratified into two cohorts: those who received tyrosine kinase inhibitors (TKIs), such as sorafenib or lenvatinib, as their first-line systemic therapy, and those who received immune checkpoint inhibitors (ICIs), such as atezolizumab plus bevacizumab, as their first-line systemic therapy. The primary endpoint is the objective response rate (ORR) assessed by an independent review committee according to RECIST v1.1 criteria.

Dr. Youzhi Tong, Founder, Chairman, and CEO of Kintor, stated that following its approval in the United States last year, the combination of atezolizumab and bevacizumab (A+B) has replaced sorafenib or lenvatinib as the primary first-line treatment for advanced hepatocellular carcinoma (HCC) and is gradually being adopted in other countries. However, the second-line treatment landscape after A+B remains unclear, posing a significant challenge to our clinical strategy for combination therapy during this period of transition. After multiple communications with the FDA, we have obtained approval to proceed with concurrent exploratory second-line clinical studies. This approach aims to accelerate the clinical development process, seeking conditional Phase II approval through Multi-Regional Clinical Trials (MRCT) or conducting pivotal Phase III registration trials.

Note: GT90001 is a potential first-in-class antibody for which Kintor obtained an exclusive global license from Pfizer in 2018, covering all tumor indications.

About Kintor

Kintor was founded in 2009, focusing on the research, development, and industrialization of potential “best-in-class” and “first-in-class” innovative drugs, with a commitment to becoming a leading enterprise in the research, development, and commercialization of innovative therapies. The company was established under the leadership of national-level talent. After years of development, it has centered its efforts on androgen receptor (AR)-related diseases, developing a multi-channel product portfolio that addresses global high-incidence cancers and other disease areas with unmet clinical needs, including COVID-19, prostate cancer, breast cancer, liver cancer, hair loss, and acne. Kintor has proactively built a diversified product pipeline comprising small-molecule innovative drugs, biologic innovative drugs, and combination therapies. This includes five products currently undergoing clinical studies—such as androgen receptor (AR) antagonists, ALK-1 monoclonal antibodies, mTOR kinase inhibitors, and Hedgehog inhibitors—as well as candidates in preclinical research, including PD-L1/TGF-β dual-target antibodies, AR degraders, and c-Myc inhibitors. The company holds more than 60 granted and pending patents worldwide, with multiple projects listed under the National Major Special Project for New Drug Innovation during China’s 12th and 13th Five-Year Plan periods. On May 22, 2020, Kintor was officially listed on the Main Board of The Stock Exchange of Hong Kong Limited, with stock code: 9939.HK. Please visit the company’s website:www.kintor.com.cn