GenFleet Receives FDA Approval for P3 Trial of GFH925 in Colorectal Cancer Treatment
FDA & EMA / 29 April 2024
GenFleet Therapeutics announced that the US Food and Drug Administration (FDA) has granted clinical trial approval for GFH925, a KRAS G12C inhibitor, in a randomized and controlled phase III study treating refractory metastatic colorectal cancer (CRC) patients. Representing the first global trial of its kind, this study aims to assess GFH925's efficacy against current standards of care, signaling a significant leap forward in CRC treatment.
The approved trial, designated GFH925X0301, will focus on refractory metastatic CRC patients harboring the KRAS G12C mutation who have either progressed after prior treatments or are intolerant to their last therapy. This multi-center, open-label, randomized, and controlled study aims to evaluate the efficacy of GFH925 compared to current standard-of-care treatments.
GenFleet's Chief Medical Official, Dr. Yu Wang, expressed gratitude for the FDA's acknowledgment of GFH925's efficacy and safety profile. Dr. Wang emphasized the trial's potential to revolutionize CRC treatment, offering hope for patients grappling with advanced-stage disease. Notably, GFH925 has already received Breakthrough Therapy Designation in China and has shown promise in treating advanced non-small cell lung cancer (NSCLC) patients with G12C mutation.
According to the GLOBOCAN 2022 report, colorectal cancer (CRC) ranks among the most prevalent cancers worldwide, with over 1.9 million new cases and over 900,000 deaths annually. Approximately 40% of CRC patients carry KRAS mutations, making it a key target for innovative therapeutic interventions.
KRAS mutation in CRC is associated with advanced disease status, poor tumor differentiation, distant metastasis, and inferior survival. Despite recent advances in cancer treatment, there remains an unmet clinical need for effective therapies, particularly for patients with KRAS mutations who have limited treatment options.
GenFleet's forward-thinking strategy extends beyond CRC, with ongoing trials exploring GFH925's potential in combination with cetuximab for advanced NSCLC. The company's commitment to global development reflects a concerted effort to address the unmet clinical needs of cancer patients worldwide.
About GFH925 and RAS
GFH925, a novel KRAS G12C inhibitor, shows promising efficacy in colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) treatment. Clinical data from phase I studies revealed significant response rates and disease control, with a median progression-free survival (PFS) of 7.6 months. It's the first China-developed KRAS G12C inhibitor accepted for NDA submission with Priority Review Designation. KRAS mutations, found in various cancers, including pancreatic, colon, and lung, underscore the therapeutic potential of GFH925. Its mechanism involves targeting KRAS G12C mutation irreversibly, inhibiting downstream signaling pathways, inducing apoptosis, and cell cycle arrest.
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