Enliven reports Phase 1 CML data for ELVN-001, aligns with FDA on Phase 3 design

Enliven Therapeutics reported second-quarter 2026 financial results and a business update on August 5, 2026, covering the quarter ended June 30, 2026.

The company said in June 2026 it presented positive data from the ongoing Phase 1 "ENABLE" trial (NCT05304377) of ELVN-001, a small molecule kinase inhibitor targeting the BCR::ABL1 gene fusion, the oncogenic driver for patients living with chronic myeloid leukemia (CML)¹, at the European Hematology Association Congress. In the 80 mg once-daily Phase 1b cohort, the trial showed 61% overall major molecular response (MMR) and 48% MMR achievement by 24 weeks¹. Among patients with only one or two prior TKIs, the response rates were higher, with 67% overall MMR and 55% achieving MMR by 24 weeks¹. The company also said patients previously treated with asciminib achieved response rates comparable to the overall efficacy-evaluable population¹, and reported a favorable safety and tolerability profile with 161 patients enrolled and a median treatment duration of 35 weeks, as of the March 10, 2026 cutoff¹.

Following an End-of-Phase 1 meeting with the FDA, the 80 mg once-daily dose was selected as the recommended dose for the Phase 3 ENABLE-2 trial¹. The company said ENABLE-2 is expected to enroll CML patients previously treated with one or more TKIs, randomized to ELVN-001 or a physician's choice of an ATP-competitive TKI¹, with additional trial design details expected to be finalized following further FDA discussions, including a planned End-of-Phase 2 meeting anticipated in the third quarter of 2026¹. The FDA also granted Fast Track Designation to ELVN-001¹. Enliven said it expects to initiate the ENABLE-2 Phase 3 trial in the second half of 2026¹.

As of June 30, 2026, the company had cash, cash equivalents and marketable securities totaling $895.2 million, which is expected to provide cash runway into 2030¹.