Full Press Release Details
Reported cumulative MMR rate of 44% (16 of 36) by 24 weeks with 26% (7 of 27) of patients achieving MMR by 24 weeks, which continues to compare favorably to precedent Phase 1 trials of approved BCR::ABL1 TKIs
ELVN-001 continues to demonstrate a favorable safety and tolerability profile across all dose levels with 74 patients enrolled and a median treatment duration of ~26 weeks at cutoff
Presentation at EHA will include updated data with additional patients and longer treatment duration
Enliven will host a webcast and conference call on June 13 at 1:30 p.m. ET
BOULDER, Colo. , May 14, 2025 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN ), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today announced updated, 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) 2025 Congress taking place June 12-15 in Milan, Italy , and virtually. Updated data will be presented during an oral presentation at the conference on Friday, June 13 , at 5 p.m. CEST / 11 a.m. ET . Enliven management will host a webcast and conference call to discuss the data on Friday, June 13 , at 7:30 p.m. CEST / 1:30 p.m. ET .
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 CML. Data presented at EHA will be from the ongoing ENABLE Phase 1a/ 1b clinical trial, which enrolled patients with CML that have failed, are intolerant to, or are not a candidate for, available therapies known to be active for treatment of their CML ( NCT05304377 ).
"We are strongly encouraged by the consistent efficacy, safety and tolerability data from the ongoing ENABLE trial in heavily pretreated patients with CML," said Helen Collins , M.D., Chief Medical Officer of Enliven. "These data continue to demonstrate the potential for ELVN-001 to achieve a best-in-class profile compared to the available active-site TKIs. We look forward to providing additional updates at the EHA Congress in June."
Abstract Highlights
Patient Demographics
Updated Efficacy
Details of the oral presentation are as follows: Title: ENABLE: A Phase 1a/ 1b Study of ELVN-001, a selective active site inhibitor of BCR::ABL1, in patients with previously treated CML Presenter: Andreas Hochhaus , M.D. Session Title: s425 Novel approaches of CML treatment Location: Coral 2 Abstract Number: S165 Presentation Date/Time: June 13 , 5 p.m. CEST / 11 a.m. ET
The abstract is available on the EHA website . Following the presentation, a copy will be available on the " Program Presentations & Publications " section of the Company's website at www.enliventherapeutics.com .
Webcast and Conference Call Information Enliven will host a conference call with management on June 13, 2025 , at 7:30 p.m. CEST / 1:30 p.m. ET . To access the call, please dial +1 (800) 803-6955 (domestic) or (240) 220-9050 (international), and reference participant ID 631-128-259 at least 10 minutes prior to the start time and ask to be joined to the Enliven call. Accompanying slides and a link to the webcast will be available in the Investors section of the Enliven website at https://ir.enliventherapeutics.com/events . To participate in the live event, please register using this link . An archived webcast will be available following the event.
About the ENABLE Trial The ENABLE study ( NCT05304377 ) is a Phase 1 study of ELVN-001 in patients with previously treated CML. The trial is currently in Phase 1a/ 1b development and 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. Enliven is preparing for the potential start of a pivotal trial for ELVN-001 in 2026.
About ELVN-001 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 inhibitor, 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.
Head-to-Head Comparisons
The Company has not performed any head-to-head trials for ELVN-001. As a result, the data referenced in this press release is derived from different clinical trials at different points in time, with differences in trial design and patient populations. As a result, conclusions from cross-trial comparisons cannot be made.
SOURCE Enliven Therapeutics, Inc.