Announcement • 7h
Enliven Therapeutics Announces Oral Presentation At Eha 2026 Congress Featuring Additional Positive Phase 1 Clinical Trial Data for Elvn-001 in Cml
Enliven Therapeutics, Inc. announced additional, positive data from the Phase 1 ENABLE clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) in an abstract accepted for an oral presentation at the European Hematology Association (EHA) 2026 Congress taking place June 11-14 in Stockholm, Sweden and virtually. ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, the oncogenic driver for patients living with CML. Data presented at EHA will be from the ongoing ENABLE Phase 1 clinical trial, which enrolled patients with CML that is relapsed, refractory or intolerant to available tyrosine kinase inhibitors (TKIs) (NCT05304377). Patient Demographics: As of the cutoff date of December 22, 2025, 141 patients were enrolled in the ongoing Phase 1 trial across dose levels from 10-160 mg once daily (QD), and most patients (76%) remain on study with a median treatment duration of 31.7 weeks. Patients enrolled continue to be heavily pretreated, with 67% having received three or more prior unique TKIs and 24% having received five or more unique TKIs. 61% of patients had received prior asciminib, and of those patients, 92% had received three or more prior unique TKIs, and 37% had received five or more unique TKIs. 9% of patients enrolled with mutations associated with resistance to asciminib. Efficacy: In the initial 80 mg QD Phase 1b cohort (n=19), all patients were evaluable for efficacy by 24 weeks. Of these, 9/19 (47%) were in major molecular response (MMR), with 6/16 (38%) achieving MMR. In the randomized 60 mg and 120 mg QD Phase 1b cohorts (n=41), 26 patients were evaluable for efficacy by 24 weeks, reflecting their more recent enrollment. Of these, 18/26 (69%) were in MMR, with 9/17 (53%) achieving MMR. All patients who received prior asciminib in Phase 1b had an improved or stable response category by week 24. Of these, 14/27 (52%) were in MMR, with 8/21 (38%) achieving MMR. Across all Phase 1b cohorts, 100% of evaluable patients in MMR at enrollment maintained or deepened their response. These data continued to compare favorably to precedent Phase 1 MMR rates for approved BCR::ABL1 TKIs, particularly given the more heavily pretreated patient population in the ELVN-001 clinical trial. Safety Profile: ELVN-001 remains well-tolerated, consistent with its highly selective kinase profile. Less than 10% of patients had dose reductions due to treatment-emergent adverse events, and 6.4% of patients discontinued due to adverse events. The ENABLE study (NCT05304377) is a Phase 1 study of ELVN-001 in patients with previously treated CML. ENABLE is a dose escalation and expansion trial designed to evaluate safety and tolerability and to determine the recommended dose for further clinical evaluation of ELVN-001 in patients with CML with and without T315I mutations that is relapsed, refractory or intolerant to TKIs. Secondary endpoints include pharmacokinetics, MMR by central quantitative reverse transcriptase polymerase chain reaction, duration of MMR, BCR::ABL1 transcript levels and complete hematologic response. ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia. As a highly selective active-site TKI, ELVN-001 has a mechanism of action that is complementary to allosteric BCR::ABL1 inhibitors, which may play an increasingly important role in the standard of care. ELVN-001 was also designed to have activity against the T315I mutation, the most common BCR::ABL1 mutation, which confers resistance to nearly all approved TKIs, as well as activity against mutations known to confer resistance to allosteric BCR::ABL1 inhibitors.
