Enliven Therapeutics Announces Positive Data Update from Phase 1 Clinical Trial of ELVN-001 in Chronic Myeloid Leukemia

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Enliven Therapeutics, Inc.
Enliven Therapeutics, Inc.

Updated Phase 1 data presented at ESH-iCMLf 26th Annual John Goldman Conference

Reported cumulative MMR rate of 44% (8/18) by 24 weeks, with stable or deepening responses between weeks 12 and 24, which continues to compare favorably to precedent Phase 1 trials of approved BCR::ABL1 TKIs

ELVN-001 remains well-tolerated with no dose reductions reported with 39 patients enrolled and a median treatment duration of 20 weeks at cutoff

BOULDER, Colo., Sept. 28, 2024 (GLOBE NEWSWIRE) -- 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 clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) that has failed, or the patient is intolerant to or not a candidate for, available therapies known to be active for treatment of their CML (NCT05304377) at the European Society of Hematology International Chronic Myeloid Leukemia Foundation (ESH-iCMLf) 26th Annual John Goldman Conference.

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.

"I am happy to present the updated ELVN-001 Phase 1 data today at ESH-iCMLf. ELVN-001 continues to show clinical benefit in heavily pretreated CML patients,” said presenting investigator Fabian Lang, M.D., from Goethe University Hospital Frankfurt. “I am encouraged that the initial clinical profile presented in April continues to hold, even as patient numbers and the median duration of exposure increased. We continue to see categorical improvements in molecular response, and the drug remains well-tolerated with an encouraging safety profile. Despite recent advancements in the CML treatment paradigm, there continues to be a need for more efficacious and better tolerated active-site TKIs, especially for patients who have failed treatment with allosteric inhibitors. I remain excited to see the progress of ELVN-001 as the trial continues."

The updated data presented today includes 39 patients across various dose levels, 18 of whom were evaluable for molecular response by 24 weeks. Consistent with the 12-week results the Company presented in April 2024, a cumulative major molecular response (MMR) rate of 44.4% (8/18) was observed by 24 weeks in response-evaluable CML patients. Additionally, ELVN-001 continues to be well-tolerated with no dose reductions and a median treatment duration of 20 weeks.

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