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Enliven's Chronic Myeloid Leukemia Candidate Achieves MMR Rate in Phase 1 Trial
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Enliven's Chronic Myeloid Leukemia Candidate Achieves MMR Rate in Phase 1 Trial
Jun 13, 2025 4:41 AM

07:21 AM EDT, 06/13/2025 (MT Newswires) -- Enliven Therapeutics ( ELVN ) reported Friday that updated data from the phase 1 clinical study showed its ELVN-001 chronic myeloid leukemia drug attained major molecular response, or MMR, rates that compared favorably to prior early stage trials.

The company reported that ELVN-001 achieved a cumulative major molecular response, or MMR, rate of 47% or 25 of 53 patients, by 24 weeks, with 32%, or 13 of 41 patients, reaching MMR within that timeframe.

"The data from ELVN-001 are encouraging, showing an efficacy, safety and tolerability profile that compare favorably to approved BCR::ABL1 inhibitors," the company said.

The company admitted 90 participants in the trial as of April 28 throughout dose levels ranging from 10 mg daily to 80 mg twice a day, Enliven said, adding that ELVN-001 remained "well-tolerated" across all evaluated dose levels and only 3.4% of participants had dose reductions due to treatment-emergent adverse events.

Enliven said that 80% of patients remain on the trial, with a roughly 29-week median treatment time, adding that enrolled participants were "heavily" pretreated.

There were no "enhanced cardiovascular toxicity" and no-treatment related "arterial occlusive events" seen during the study, the biopharmaceutical company said.

Enliven presented these results virtually in an oral presentation at the European Hematology Association 2025 Congress taking place June 12 to June 15 in Milan, Italy.

Shares of Enliven were down 4% in recent Friday premarket activity.

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