Enliven Therapeutics, Inc. (ELVN), reported on Thursday an updated positive result from the Phase 1 ENABLE trial of ELVN-001 in patients who were previously treated for Chronic Myeloid Leukemia (CML).
Company Profile
Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on developing small-molecule precision oncology therapies. Its pipeline includes targeted kinase inhibitors designed to address unmet needs in various cancers.
Chronic Myeloid Leukemia (CML)
Chronic myeloid leukemia is a type of bone marrow cancer characterized by an increased number of white blood cells in the blood. Chromosome 9 and Chromosome 22 combine to form the breakpoint cluster region-Abelson "BCR::ABL" gene, which instructs blood cells to produce tyrosine kinase, a stimulant for blood cell proliferation. (Source: Mayo Clinic)
ELVN-001
ELVN-001 is a selective small molecule kinase inhibitor that targets the oncogenic driver, the BCR::ABL gene fusion, in patients with CML. It has a selective active site for tyrosine kinase inhibitors, which act complementary to allosteric BCR::ABL1 inhibitors.
ENABLE Study
ENABLE is a Phase 1, dose escalation and expansion trial designed to assess the safety and tolerability of ELVN-001 in patients with previously treated CML.
As of the cutoff date of March 10, 2026, the company enrolled 161 patients across dose levels ranging from 10 to 240 mg daily.
Patients enrolled were a heavily pretreated population, with 70% who received three or more unique TKIs and 23% who received five or more unique TKIs.
Additionally, 62% of the patients received prior asciminib, and they were heavily pretreated compared to the overall trial population.
Key Highlights
According to the company, the efficacy data by 24 weeks reported that out of the 90 patients enrolled in the phase 1b trial, 78 patients had BCR::ABL1 transcripts and at least one post-baseline transcript. For the major molecular response (MMR) at 24 weeks, a total of 69 patients were evaluated.
Additionally, out of the 49 patients enrolled in the 80 mg once daily (QD) Phase 1b cohort, 37 patients had a BCR::ABL1 transcript and one post-baseline transcript. For the MMR at 24 weeks, 28 patients were evaluable.
By 24 weeks, 22% of patients in the overall Phase 1b achieved the deep molecular response (DMR), and the patients in the 80 mg QD Phase 1b cohort achieved 30% DMR. Response rates were higher in patients who had received fewer prior treatments, and prior asciminib use did not appear to meaningfully impact response rates.
The company reported ELVN-001 was generally well-tolerated, and the treatment-emergent adverse events (TEAEs) in 34% of the patients were grade 3 and higher.
On the other hand, at the biologically optimal dose of 80 mg (QD), grade 3 and more TEAE were reported in 24% of the patients.
Milestones Ahead
At the end of the Phase 1 meeting with the FDA, 80 mg QD is selected as the recommended dose for the Phase 3 ENABLE-2 trial.
The company further added it will enroll patients for the ENABLE-2 pivotal trial, which is expected to initiate in the second half of this year.
ELVN is currently trading at $41.34, up 11.74%.
For comments and feedback contact: editorial@rttnews.com
Business News
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.