Enliven Therapeutics Reports Promising Phase 1b Results for ELVN-001 in Treatment-Resistant Chronic Myeloid Leukemia
核心洞察
Enliven Therapeutics announced encouraging Phase 1b ENABLE trial data for ELVN-001 in chronic myeloid leukemia (搜索) patients who are relapsed, refractory, or intolerant to available tyrosine kinase inhibitors.
The trial demonstrated major molecular response rates of 38% in the 80 mg cohort and 53% in randomized 60-120 mg cohorts, with deep molecular response rates of 16% and 35% respectively.
ELVN-001 showed a favorable safety profile with no maximum tolerated dose identified and no new safety signals across all evaluated doses.
Enliven Therapeutics Inc. reported encouraging initial results from its ongoing Phase 1b ENABLE trial of ELVN-001 in patients with chronic myeloid leukemia (搜索) (CML (搜索)) that is relapsed, refractory, or intolerant to available tyrosine kinase inhibitors (TKIs). The positive data drove the company's stock up 50.42% to $23.27, with trading volume reaching 6.61 million shares compared to the average volume of 631.52 thousand.
Trial Design and Patient Population
As of the December 22, 2025 cutoff date, 60 heavily pre-treated patients were enrolled in the Phase 1b study. The trial evaluated ELVN-001 across multiple dosing cohorts, including an 80 mg once-daily cohort and randomized 60 mg and 120 mg cohorts.
Efficacy Results Show Promise
In the 80 mg once-daily Phase 1b cohort (n=19), all patients were evaluable for efficacy by 24 weeks. The mature data demonstrated major molecular response (MMR) achievement rates of 38% and Deep Molecular Response (DMR) rates of 16%. These results compare favorably to precedent Phase 1 trials of approved BCR::ABL1 (搜索) TKIs, including Novartis AG's Scemblix (asciminib).
The randomized 60 mg and 120 mg cohorts (n=41) showed even more encouraging results, with MMR achievement rates of 53% and DMR rates of 35%. Notably, across all Phase 1b cohorts, 100% of evaluable patients who were in MMR at enrollment maintained or deepened their response.
Safety Profile Remains Favorable
Clinical activity was observed at doses ranging from 60 mg to 120 mg once daily, with no clear evidence of dose response in either efficacy or safety within this range. ELVN-001 continued to demonstrate a favorable safety and tolerability profile across all evaluated doses. The safety profile observed in these Phase 1b cohorts remained consistent with previously reported data, with no maximum tolerated dose identified and no new safety signals detected.
Path Forward to Phase 3
Based on these positive Phase 1b results, Enliven Therapeutics plans to initiate the ENABLE-2 Phase 3 trial of ELVN-001 in the second half of 2026. The advancement to Phase 3 represents a significant milestone for the company's lead asset in addressing the unmet medical need for patients with treatment-resistant CML (搜索).