Jingfang Pharmaceutical-B (02595): The registered clinical trial of GFH375 for the treatment of metastatic pancreatic cancer was launched at the first research center as the world's first phase III study of single-agent controlled chemotherapy with an oral KRAS G12D inhibitor

According to Zhitong Finance App, Jingfang Pharmaceutical-B (02595) announced that a registered phase III trial (GFH375X1301) of oral administration of the KRAS G12D (ON/OFF) inhibitor GFH375 to treat patients with treated KRAS G12D mutant metastatic pancreatic cancer () has started at Peking University Cancer Hospital. Currently, GFH375 is in the first tier of oral KRAS G12D inhibitors in the world. A number of GFH375 (known as VS-7375 outside of China) single drugs and combination therapies are being clinically explored in China (led by Jingfang) and overseas (led by Jinfang partner Verastem Oncology), including GFH375 combined chemotherapy (albumin paclitaxel and gemcitabine, AG) for first-line treatment of advanced pancreatic ductal adenocarcinoma (PDAC); in addition, GFH375/VS-7375 has obtained FDA Fast Track Eligibility Identify and treat patients with locally advanced and metastatic KRAS G12D mutant PDAC in all lines.

This multi-center, open-label, randomized controlled phase III trial (GFH375X1301) will be conducted at about 40 centers, and it is planned to enroll approximately 320 patients with metastatic pancreatic cancer who have previously received at least one standard systemic treatment. According to Sullivan data, there will be more than 770,000 new cases of pancreatic cancer worldwide in 2037. Pancreatic cancer is highly malignant, and the 5-year survival rate is less than 10%. Currently, pancreatic cancer treatment is still mainly chemotherapy drugs. The objective remission rate (ORR) for second-line to third-line treatment is only 10-20%, and there is no standard treatment plan for third-line and above treatment. Research literature shows that nearly 40% of pancreatic cancer patients have KRAS G12D mutations, and no relevant target drugs have been approved for marketing in the world; KRAS G12D mutations are independent prognostic markers of poor advanced PDAC response rate and overall survival, and KRAS G12D mutations play a key role in regulatory T cell transformation, which can promote the formation of an immunosuppressive tumor microenvironment and cause patients to respond poorly to immune checkpoint inhibitors.

Dr. Wang Yu, Chief Medical Officer of Jingfang, said, “This is the world's first registered clinical study of oral RAS inhibitors to treat pancreatic cancer. This important milestone reflects the clinical development and execution capabilities of the Jingfang clinical team, as well as the company's ability to develop integrated new drugs that are deeply involved in the RAS therapy matrix. GFH375 entered clinical trials last year, obtained excellent single-drug phase I/II study data this year, and recently entered multiple single-drug and combination therapy trials. We expect this product to achieve positive results in this registered study (GFH375X1301) and benefit patients as soon as possible. We also look forward to Jinfang RAS targeted drugs represented by GFH375 to achieve more breakthroughs in the future and form a synergetic treatment matrix targeting pancreatic cancer with the company's cachexic dual antagonists.”