Enliven Therapeutics, Inc. (NASDAQ: ELVN) has just announced positive data from the phase 1 enable clinical trial of ELVN-001 in patients with chronic myeloid leukemia (CML). The company reported a cumulative major molecular response (MMR) rate of 47% (25 of 53) by 24 weeks, with 32% (13 of 41) of patients achieving MMR by 24 weeks. This demonstrates a favorable safety and tolerability profile across all dose levels, with 90 patients enrolled and a median treatment duration of approximately 29 weeks at cutoff.
The patients enrolled in the trial were heavily pretreated, with 67% receiving three or more unique prior tyrosine kinase inhibitors (TKIs), including 58% who received prior asciminib and 43% who received prior ponatinib. Additionally, 72% of patients had discontinued their prior TKI due to lack of efficacy.
Of the enrolled patients, 53 with typical bcr::abl1 transcripts and without t315i mutations were evaluable for MMR by 24 weeks. The data showed that 25 of 53 (47%) evaluable patients were in MMR by 24 weeks, with 13 of 41 (32%) achieving and 12 of 12 (100%) maintaining MMR. Notably, of those resistant to their last TKI, 41% were in MMR by 24 weeks, and of those previously treated with asciminib or ponatinib, 35% were in MMR by 24 weeks.
The safety profile of ELVN-001 remains well-tolerated across all evaluated doses, with only 3.4% of patients experiencing dose reductions due to treatment-emergent adverse events (TEAEs) and 4.6% of patients discontinuing due to TEAEs. Additionally, the majority of TEAEs were low frequency and low grade, with no evidence of enhanced cardiovascular toxicity or treatment-related arterial occlusive events.
The pharmacokinetic (PK) profile supports once-daily dosing with flexible administration requirements and low potential for drug-drug interactions.
Enliven is preparing for the potential start of a pivotal trial for ELVN-001 in 2026, and the company expressed confidence in ELVN-001 and its potential positioning in the future in the CML treatment paradigm.
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 CML. Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to address unmet needs in precision oncology.
As a result of these announcements, the company's shares have moved 0.28% on the market, and are now trading at a price of $19.66. If you want to know more, read the company's complete 8-K report here.
