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 presented updated positive data from the Phase 1 ENABLE clinical trial evaluating ELVN-001 in patients with previously treated chronic myeloid leukemia (CML). An oral presentation will be delivered later today at the European Hematology Association (EHA) 2026 Congress, taking place June 11-15 in Stockholm, Sweden, and virtually. The Company also provided an update on recent regulatory interactions with the Food and Drug Administration (FDA). Enliven will host a webcast and conference call today, June 11, at 8:30 a.m. ET / 2:30 p.m. CEST.
"Despite recent advances in CML treatment, there remains a need for highly effective therapies with excellent safety and tolerability profiles optimized for long-term treatment and capable of deep and durable molecular responses," said Dennis Kim, M.D., Professor of Medicine in the Department of Medical Oncology and Hematology at the Princess Margaret Cancer Centre, Canada. "The updated data from the ENABLE trial are very promising and encouraging. The trial demonstrated meaningful responses across lines of therapy in heavily pretreated patients, including responses in patients who had shown a lack of efficacy to the most effective approved therapies. Further, ELVN-001 demonstrated a favorable safety and tolerability profile, reflecting its high selectivity. I look forward to the initiation of the planned Phase 3 ENABLE-2 trial, which could establish ELVN-001 as an important new treatment option for patients with previously treated CML."
"These promising results continue to showcase the consistency of ELVN-001's overall profile and reinforce its potential to be a best-in-class ATP-competitive inhibitor with differentiated activity relative to allosteric inhibitors," said Helen Collins, M.D., Chief Medical Officer of Enliven. "In these data, we observed higher response rates in patients treated in earlier lines of therapy, and comparable response rates regardless of prior asciminib exposure. We are also thrilled by the outcome of our recent End-of-Phase 1 meeting with the FDA, where we reached alignment on the 80 mg once daily dose and the inclusion of patients who have received at least one prior TKI in the planned ENABLE-2 Phase 3 trial. This is an important milestone as we advance towards initiating ENABLE-2 later this year."
ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, the oncogenic driver for patients living with CML. Data presented at EHA are from the ongoing ENABLE Phase 1 clinical trial, which enrolled patients with CML that is relapsed, refractory or intolerant to available tyrosine kinase inhibitors (TKIs) (NCT05304377).
ELVN-001 Updated Data Highlights
ENABLE Has Enrolled a Heavily Pretreated Patient Population
- As of the cutoff date of March 10, 2026, 161 patients were enrolled in the ongoing Phase 1 trial across dose levels ranging from 10-240 mg daily.
- Most patients (76%) remain on study with a median treatment duration of 35 weeks.
- Patients enrolled were heavily pretreated, with 70% having received three or more prior unique TKIs and 23% having received five or more unique TKIs.
- 62% of patients received prior asciminib, and these patients were more heavily pretreated than the overall trial population: 93% received three or more prior unique TKIs, and 34% received five or more unique TKIs.
- 8% of patients enrolled with mutations associated with resistance to allosteric inhibitors, increasing from 4% in Phase 1a to 11% in Phase 1b.
Encouraging ELVN-001 Efficacy Data by 24 Weeks
- Of the 90 patients enrolled in the Phase 1b, 78 had typical BCR::ABL1 transcripts and had at least one post-baseline transcript; 69 patients were evaluable for major molecular response (MMR) by 24 weeks.
- Additionally, of the 49 patients enrolled in the 80 mg once daily (QD) Phase 1b cohort, 37 had typical BCR::ABL1 transcripts and had at least one post-baseline transcript; 28 patients were evaluable for MMR by 24 weeks.
| Cohort (n = evaluable for MMR) | Phase 1b | Phase 1b 80 mg QD Cohort |
| Overall MMR | 54% (n=69) | 61% (n=28) |
| Achieved MMR | 40% (n=53) | 48% (n=21) |
| Maintained MMR | 100% (n=16) | 100% (n=7) |
- Deep Molecular Response (DMR) achievement rates were also encouraging.
- By 24 weeks, DMR was achieved in 22% of patients in the overall Phase 1b and 30% of patients in the 80 mg QD Phase 1b cohort.
- Response rates were higher in less heavily pretreated patients, and prior asciminib exposure did not meaningfully impact response rates.
| Achieved Response Rates by 24-weeks (n = evaluable for MMR) | ||
| Prior number of unique TKIs: | Phase 1b (n=69) | Phase 1b post-asciminib (n=43) |
| 1-2 | 55% (n=27) | 60% (n=6) |
| 3-4 | 32% (n=26) | 28% (n=22) |
| 5+ | 29% (n=16) | 29% (n=15) |
ELVN-001's Safety Profile Consistent with High Selectivity for ABL1
- ELVN-001 was generally well-tolerated, consistent with its high selectivity.
- 6% of patients discontinued due to adverse events.
- The majority of treatment-emergent adverse events (TEAEs) were Grade 1 or 2.
- Grade ≥3 TEAEs were reported in 53/158 (34%) patients overall; with thrombocytopenia (6%), neutropenia (6%) and lipase elevation (6%) as the most common.
- At the biologically optimal dose of 80 mg QD (n=62), Grade ≥3 TEAEs were reported in 15/62 (24%) patients, with thrombocytopenia (6%) being the only Grade ≥3 TEAE reported in >5% of patients.
Key Outcomes from the End-of-Phase 1 Meeting with the FDA
- 80 mg QD selected as the recommended dose for Phase 3 ENABLE-2 trial.
- ENABLE-2 is expected to enroll patients with CML previously treated with one or more TKIs, and to be randomized to receive either ELVN-001 or physician's choice of an ATP-competitive TKI.
- Additional details of the Phase 3 trial design are expected to be finalized following further discussions with the FDA, including at a planned End-of-Phase 2 meeting anticipated in the third quarter of 2026.
The oral presentation titled: "ENABLE: Up
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