Enliven reports ‘positive’ initial Phase 1b data for ELVN-001 in CML

Enliven (ELVN) Therapeutics announced positive initial data from the ongoing Phase 1b ENABLE clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia that is relapsed, refractory or intolerant to available tyrosine kinase inhibitors. “We are excited about these initial Phase 1b data, the progress we made throughout 2025 and the year ahead. Our data continue to demonstrate that ELVN-001 has the potential to be the best-in-class active-site TKI for the treatment of CML and an important treatment option across all lines of therapy,” said Helen Collins, M.D., Chief Medical Officer of Enliven. “Momentum has been building over the last year leading to significant interest in our Phase 3 clinical trial from sites all around the world. We are preparing for upcoming regulatory interactions with the FDA to align on dose selection and support initiation of the Phase 3 trial in the second half of 2026.”