Genfleet targets relapsed pancreatic cancer

In the crowded KRAS G12D space, GenFleet Therapeutics has just listed on clinicaltrials.gov a 588-patient phase 3 trial that will test VS-7375 (GFH375), its KRAS G12D inhibitor, head-to-head against chemotherapy in relapsed pancreatic cancer. The Chinese study is set to begin in December and enrol patients with G12D mutations who have already been treated with at least one prior systemic therapy, excluding pan-RAS/KRAS or KRAS G12D inhibitors. This is a different population to that in Jiangsu HengRui’s recently listed first-line pancreatic cancer trial, also to start this month. GenFleet’s trial will have PFS and OS as co-primary endpoints, with a completion date of June 2027. The programme’s US expansion is being led by Verastem, which licensed VS-7375 in January after partnering with GenFleet on RAS-targeted agents since 2023. Its US phase 3 is expected to begin in the first half of next year. Early signals of activity have already emerged. At ASCO, the partners reported a 52% ORR in pancreatic cancer, followed by a 41% ORR presented at ESMO. Verastem also reported tumour shrinkage in four of five evaluable patients in its ongoing US phase 1/2 trial, but hasn't disclosed any responses. A bigger update is expected in 2026.

KRAS G12D-targeting projects in late-stage development

Source: OncologyPipeline.