GSK's IPF drug GSK3915393 fails Phase 2 on futility; expanded access opens for velzatinib in GIST

GSK had two items post this week, one terminated trial with results and one new expanded access program.

• The Phase 2 "TRANSFORM" trial of GSK3915393 in idiopathic pulmonary fibrosis enrolled 158 participants¹, with the drug given as 80 milligrams orally twice daily for 26 weeks¹. The study met futility criteria at a pre-planned interim analysis, showing no clinical efficacy of the investigational drug, leading the sponsor to terminate the study¹. Results were first posted 2026-09-18, with an actual primary completion date of 2025-10-01¹.
• GSK opened a new expanded access program making velzatinib (GSK6042981, also known as IDRX-42) available to individual patients with gastrointestinal stromal tumors who carry a KIT mutation. Eligible patients must be diagnosed with Gastrointestinal Stromal Tumour (GIST) and positive for a KIT mutation (in one of exons 9, 11, 13, 17), and have had at least 3 prior lines of therapy². Access also requires that there is no satisfactory alternative treatment for the patient, that the benefit of using the drug is believed to outweigh the risk, and that the patient does not qualify for other ongoing clinical trials².