FDA Approves Clinical Trial for GFH925 (KRAS G12C Inhibitor) Monotherapy in Phase III Registrational Study Treating Metastatic CRC
“We appreciate the FDA’s recognition of GFH925′ efficacy and safety profile, as this is our first global phase III monotherapy study in treating advanced stage CRC. We believe the approval of our proposed trial design highlights the potential of GFH925 monotherapy in this indication, thus bringing more therapeutic options and clinical benefits to the patients. This is a significant step forward in the development of GFH925, paving the way for its potential future use as a front-line treatment for CRC. “stated Yu Wang, Ph.D/M.D., Chief Medical Official of GenFleet. “Additionally, the study of GFH925 in combination with cetuximab is ongoing in Europe treating advanced NSCLC in the first-line setting and the phase II trial has completed the enrollment; the preliminary data analysis of this combination study, accepted as a late breaking abstract, has been selected for oral presentation during the 2024 ASCO annual meeting. GFH925’s global development reflects GenFleet’s forward-thinking strategy, the expertise of our clinical team and the deep understanding of biology for our RAS-targeted pipeline.”
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