Enliven reports 47% cumulative MMR by 24 weeks for ELVN-001 in Phase 1 CML trial; well-tolerated

Enliven Therapeutics, Inc.

47% of evaluable patients (25/53) achieved MMR by 24 weeks; 32% (13/41) achieved MMR, comparing favorably to asciminib's 24% in Phase 1.
90 patients enrolled; 80% remain on study with median treatment duration ~29 weeks; heavily pretreated (67% received ≥3 prior TKIs).
Safety: only 3.4% dose reductions, 4.6% discontinuations due to AEs; no treatment-related arterial occlusive events; no MTD reached.
PK supports once-daily dosing with food flexibility and low drug-drug interaction potential.
Company expects to initiate first head-to-head Phase 3 pivotal trial in 2026.

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