Oral KRAS G12D inhibitor GFH375 produces ORR 40.7% and DCR 96.7% in previously treated KRAS G12D pancreatic ductal adenocarcinoma: Key readouts from ESMO 2025

Highlights

– GFH375, an oral KRAS G12D selective inhibitor, demonstrated an investigator-assessed objective response rate (ORR) of 40.7% and disease control rate (DCR) of 96.7% in previously treated KRAS G12D-mutant pancreatic ductal adenocarcinoma (PDAC) in a multicenter phase I/II study presented at ESMO 2025.

– Median progression-free survival (PFS) was 5.52 months (90% CI 4.27–7.20); median overall survival (OS) not reached at median follow-up 5.65 months; safety profile was manageable with grade ≥3 treatment-emergent adverse events (TEAEs) in 31.8% and no treatment-related deaths reported.

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