Enliven Therapeutics, Inc. 8-K

What Happened
Enliven Therapeutics (ELVN) announced on June 11, 2026 updated Phase 1 ENABLE data for ELVN‑001 in chronic myeloid leukemia (CML) and reported key outcomes from an End‑of‑Phase 1 meeting with the U.S. Food and Drug Administration (FDA). As of the March 10, 2026 cutoff, the trial had enrolled 161 patients across doses from 10–240 mg daily; the FDA-selected recommended dose for Phase 3 (ENABLE‑2) is 80 mg once daily (QD). The company said ENABLE‑2 will randomize previously treated CML patients to ELVN‑001 or physician’s choice of an ATP‑competitive TKI, with additional Phase 3 details to be finalized after further FDA discussions (End‑of‑Phase 2 meeting planned Q3 2026).

Key Details

• Trial enrollment and population: 161 patients enrolled (cutoff March 10, 2026); 76% remain on study; median treatment duration 35 weeks. Patients were heavily pretreated: 70% had ≥3 prior unique TKIs; 23% had ≥5; 62% had prior asciminib.
• Efficacy by 24 weeks (Phase 1b evaluable patients): 69 patients evaluable for major molecular response (MMR); MMR rate 54% overall (phase 1b) and 61% in the 80 mg QD cohort (n=28). Deep molecular response (DMR) by 24 weeks: 22% overall Phase 1b and 30% in the 80 mg QD cohort. Response rates were higher in less‑heavily pretreated patients; prior asciminib exposure did not meaningfully reduce response rates.
• Safety: ELVN‑001 was generally well tolerated. 6% discontinued for adverse events. Grade ≥3 treatment‑emergent adverse events (TEAEs) occurred in 34% (53/158) overall — most common were thrombocytopenia, neutropenia and lipase elevation (each 6%). At the 80 mg QD dose (n=62), Grade ≥3 TEAEs were 24%, with thrombocytopenia the only ≥5% event (6%).
• Regulatory/next steps: 80 mg QD chosen for Phase 3 ENABLE‑2, which will enroll patients previously treated with ≥1 TKI; trial design details to be finalized after further FDA meetings.

Why It Matters
For investors, the filing provides two material points: (1) encouraging efficacy signals (MMR and DMR rates at 24 weeks) in a heavily pretreated CML population, and (2) a clear regulatory path forward with the FDA‑endorsed Phase 3 dose (80 mg QD) and a planned randomized ENABLE‑2 trial. The safety profile shown at the selected dose appears manageable based on the disclosed rates. These facts support clinical advancement of ELVN‑001 but are preliminary (early‑phase data), and the company reiterates customary forward‑looking cautions and the absence of head‑to‑head comparisons.