劲方医药-B(02595)：GFH375治疗转移性胰腺癌注册性临床试验在首家研究中心启动 为全球首个口服KRAS G12D抑制剂单药对照化疗III期研究

Core Viewpoint - The announcement highlights the initiation of a pivotal Phase III trial (GFH375X1301) for the oral KRAS G12D inhibitor GFH375, targeting previously treated patients with metastatic pancreatic cancer, marking a significant advancement in the treatment landscape for this aggressive disease [1][2]. Group 1: Clinical Development - GFH375 is currently in the leading tier of global oral KRAS G12D inhibitors, with multiple clinical explorations ongoing both in China and internationally [1]. - The Phase III trial will be conducted at approximately 40 centers, aiming to enroll around 320 patients who have previously received at least one standard systemic treatment for metastatic pancreatic cancer [2]. - GFH375 has received FDA Fast Track designation for the treatment of locally advanced and metastatic KRAS G12D mutant pancreatic ductal adenocarcinoma (PDAC) [1]. Group 2: Market Context - Pancreatic cancer is characterized by high malignancy and poor prognosis, with a 5-year survival rate of less than 10%, and the global incidence of new cases is projected to exceed 770,000 by 2037 [2]. - Current treatment options primarily involve chemotherapy, with objective response rates (ORR) for second-line to third-line treatments only ranging from 10% to 20%, and no standard treatment available for third-line and beyond [2]. - Nearly 40% of pancreatic cancer patients exhibit KRAS G12D mutations, which are independent prognostic markers associated with poor response rates and overall survival [2]. Group 3: Company Insights - The Chief Medical Officer of the company emphasized that this is the first global oral RAS inhibitor clinical study for pancreatic cancer, showcasing the company's capabilities in clinical research and integrated drug development [3]. - The company anticipates positive outcomes from the GFH375X1301 trial, which could benefit patients and lead to further breakthroughs in RAS-targeted therapies [3]. - GFH375 is expected to synergize with the company's dual antibody therapy for a comprehensive treatment approach to pancreatic cancer [3].