GSK moves fast in GIST

GSK is wasting little time trying to get a clinical win out of last year’s $1bn buyout of IDRx. After moving straight into phase 3 development with the KIT inhibitor acquired from that deal, the company is preparing to expand pivotal trials into earlier stages of gastrointestinal stromal tumours (GISTs). As announced during its fourth-quarter earnings call on Wednesday, GSK plans to launch a new phase 3 trial evaluating GSK604298, now known by its new non-proprietary name velzatinib, in first-line GIST in the second half of 2026. The move was, to some extent, baked into the design of the phase 1 Strategist-1 study, which included a cohort of treatment-naive patients. However, GSK has yet to release data from that cohort, leaving questions about how much efficacy the inhibitor can deliver up front. Still, GSK appears to be moving fast to overtake its competitor Cogent Biosciences, which is expected to kick off a phase 2 trial of its own KIT inhibitor bezuclastinib in the first-line setting in mid-2026. That trial will test the combination of bezuclastinib with Gleevec, which has been the standard of care in the setting ever since its approval in the early 2000s. 

Velzatinib phase 3 studies

Note: *assumed, as this information has not been publicly disclosed. Source: OncologyPipeline.