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Enliven Therapeutics Announces Clinical Data in CML Patients with Atypical Fusion Transcripts at ASH 2025 Annual Meeting
ELVN-001 demonstrates encouraging anti-CML activity in heavily pretreated patients with atypical fusion transcripts Growing unmet need for patients with
About this update from Enliven Therapeutics, Inc.
[{"type":"text","content":"\n ELVN-001 demonstrates encouraging anti-CML activity in heavily pretreated patients with atypical fusion transcripts \n \n \n Growing unmet need for patients with atypical transcript e13a3, which is resistant to TKIs targeting the myristoyl pocket\n \n \n BOULDER, Colo., Nov. 3, 2025 /PRNewswire/ -- 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 announced the Company will present data from the ongoing ENABLE Phase 1a/1b clinical trial of ELVN-001 on a subset of chronic myeloid leukemia (CML) patients, specifically in patients with atypical fusion transcripts, at the 67th Annual American Society of Hematology (ASH) 2025 Annual Meeting and Exposition, taking place December 6-9, 2025, in Orlando, Florida.\n \"Approximately 2–4% of people living with CML have an atypical BCR::ABL1 fusion transcript – a patient population that is increasing in clinical relevance. The NCCN Guidelines now note that asciminib, an allosteric TKI, is contraindicated for many patients with CML with specific atypical transcripts\" said Helen Collins, M.D., Chief Medical Officer of Enliven Therapeutics. \"We observed encouraging anti-CML activity in the subset of patients with CML in the ENABLE study with atypical transcripts. These findings provide an early signal of ELVN-001's potential to address a growing unmet medical need where allosteric inhibitors fall short, and we look forward to presenting additional data at ASH 2025.\"\n \n Abstract Highlights\n \n \n Patient Demographics\n \n As of the cutoff date of April 28, 2025, six patients with previously treated chronic phase CML who had an atypical transcript received ELVN-001 at doses from 20 mg to 80 mg twice daily (BID) in the dose escalation phase of the ENABLE study. Testing for molecular response is non-standardized for atypical transcripts and was therefore assessed locally by individual molecular response.\n \n Efficacy\n \n Of the six enrolled patients with atypical transcripts, four patients had a baseline transcript available and thus could be assessed for efficacy. ELVN-001 demonstrated encouraging anti-CML activity in patients with atypical transcripts, including in patients with the e13a3 transcript, which is resistant to TKIs targeting the myristo...