Enliven reports 61% overall MMR at 80 mg QD in Phase 1b; FDA aligns on Phase 3 design for ELVN-001

Enliven Therapeutics, Inc.

161 patients enrolled; median treatment duration 35 weeks; 76% remain on study as of March 10, 2026 cutoff.
61% overall MMR and 48% achieved MMR by 24 weeks in the 80 mg QD Phase 1b cohort (n=28 evaluable).
70% of patients had 3+ prior TKIs; 62% had prior asciminib; response rates comparable regardless of prior asciminib exposure.
Only 6% discontinued due to adverse events; Grade ≥3 TEAEs at 80 mg QD were 24% with thrombocytopenia the most common at 6%.
FDA endorsed 80 mg QD as Phase 3 dose and 2L+ patient population; ENABLE-2 pivotal trial expected to initiate H2 2026.

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