GenFleet-B (02595) has announced that GFH375/VS-7375, an oral KRAS G12D inhibitor, has achieved encouraging progress across multiple domestic and overseas clinical studies, with the latest data from these studies now released.
GFH375 has so far obtained three Breakthrough Therapy Designations (BTD) in China for the treatment of KRAS G12D-mutant pancreatic cancer, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC), and has entered two registrational Phase III studies as a monotherapy for pancreatic cancer and NSCLC.
The company's overseas partner Verastem Oncology (Verastem) is expected to launch a registrational Phase III study of VS-7375 in multiple combination regimens (combined with anti-EGFR therapy or chemotherapy) for first-line treatment of PDAC by the end of this year, with progression-free survival (PFS) and objective response rate (ORR) as dual primary endpoints and overall survival (OS) as a secondary endpoint. A consensus on the study protocol has already been reached with the U.S. Food and Drug Administration (FDA).
Dr. Wang Yu, Chief Medical Officer of GenFleet, stated: "We are delighted to see the preliminary efficacy of GFH375 in combination with cetuximab for the treatment of colorectal cancer in domestic studies, as well as the superior data demonstrated by GFH375/VS-7375 across multiple overseas trials. GFH375 is the world's first oral KRAS G12D inhibitor to enter Phase III studies for both NSCLC and pancreatic cancer; the product is also expected to enter the world's first Phase III first-line study of a KRAS G12D inhibitor combined with anti-EGFR therapy overseas by the end of this year as a first-line chemotherapy-free treatment regimen. We look forward to more innovative monotherapy and combination therapies of GFH375/VS-7375 bringing hope to patients worldwide."
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