Genfleet targets relapsed pancreatic cancer

In the crowded KRAS G12D space GenFleet Therapeutics is to begin a 588-patient phase 3 trial of 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, a new clinicaltrials.gov entry reveals, 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 from 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.