On June 11, 2026 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported 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) (Free EHA Whitepaper) 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.
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"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 (Free EHA Whitepaper) 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: Updated Efficacy and Safety Results of ELVN-001, a Novel Selective ATP-Competitive Inhibitor of BCR::ABL1, in Patients with Previously Treated CP-CML" will be presented today at 5:45 p.m. CEST during the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Stockholm, Sweden, by Dennis Kim, M.D., Professor of Medicine, Department of Medical Oncology and Hematology at the Princess Margaret Cancer Centre, Canada. A copy of the presentation will be available on the "Program Presentations & Publications" section of the Company’s website at www.enliventherapeutics.com.
Webcast and Conference Call Information
Enliven will host a live webcast and conference call today at 8:30 a.m. ET / 2:30 p.m. CEST. To participate in the live event, please register using this link. Following registration, participants will have access to dial in numbers and a unique passcode should they prefer to participate by phone. The event and accompanying slides can also be accessed by visiting the investor relations section of the Company’s website at View Source An archived webcast will be available on the Company’s website following the event.
About the ENABLE Trial
The ENABLE study (NCT05304377) is a Phase 1 study of ELVN-001 in patients with previously treated CML. ENABLE is a dose escalation and expansion trial designed to evaluate safety and tolerability and to determine the recommended dose for further clinical evaluation of ELVN-001 in patients with CML with and without T315I mutations that is relapsed, refractory or intolerant to TKIs. Secondary endpoints include pharmacokinetics, MMR by central quantitative reverse transcriptase polymerase chain reaction, duration of MMR, BCR::ABL1 transcript levels and complete hematologic response.
About ELVN-001
ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia. ELVN-001, a highly selective active-site TKI, has a mechanism of action that is complementary to allosteric BCR::ABL1 inhibitors, which may play an increasingly important role in the standard of care. ELVN-001 was designed to have activity against the T315I mutation, the most common BCR::ABL1 mutation, which confers resistance to nearly all approved TKIs, as well as activity against mutations known to confer resistance to allosteric BCR::ABL1 inhibitors.
(Press release, Enliven Therapeutics, JUN 11, 2026, View Source [SID1234666582])