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Enliven Therapeutics Announces Positive Proof of Concept Data from Phase 1 Clinical Trial of ELVN-001 in Chronic Myeloid Leukemia

Achieved initial cumulative MMR rate of 44% (7/16) by 12 weeks in response-evaluable patients, which compares favorably to precedent Phase 1 trials of

articleEnliven Therapeutics, Inc.April 11, 20244/company/enliven-therapeutics-inc/news/enliven-therapeutics-announces-positive-proof-of-concept-data-from-phase-1-clinical
Enliven Therapeutics Announces Positive Proof of Concept Data from Phase 1 Clinical Trial of ELVN-001 in Chronic Myeloid Leukemia

About this update from Enliven Therapeutics, Inc.

[{"type":"text","content":"Achieved initial cumulative MMR rate of 44% (7/16) by 12 weeks in response-evaluable patients, which compares favorably to precedent Phase 1 trials of approved BCR::ABL1 TKIs Achieved initial cumulative MMR rate of 44% (4/9) by 12 weeks in response-evaluable patients who were previously treated with asciminib ELVN-001 was well tolerated with no ≥ Grade 3 treatment-related non-hematologic toxicities reported Company to host virtual event with Key Opinion Leaders at 8:00 AM ET Today BOULDER, Colo., April 11, 2024 (GLOBE NEWSWIRE) -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage precision oncology company focused on the discovery and development of next-generation small molecule kinase inhibitors, today announced positive proof of concept data from the Phase 1 clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) who are relapsed, refractory, or intolerant to available tyrosine kinase inhibitors (TKIs) (NCT05304377). 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. \"Significant advancements have been made over the past few decades for patients with CML, and the approved TKIs provide important treatment options for patients with CML. However, there are limitations with the available therapies, including intolerance or resistance, that result in inadequate target coverage, the loss of molecular response and disease progression in many patients,\" said presenting investigator Fabian Lang, M.D., from Goethe University Hospital. \"Similar to our experience with previous successful Phase 1 trials in CML, ELVN-001 looks promising. The preliminary data support that ELVN-001 is a potent and highly selective BCR::ABL1 inhibitor that has activity in heavily pre-treated patients, including post-asciminib patients.\" “We are excited to present the first look at the safety and clinical activity of ELVN-001, which we believe supports the potential for ELVN-001 to address the limitations of the available active-site TKIs,” said Helen Collins, M.D., Chief Medical Officer of Enliven. “Across a wide dose range, ELVN-001 demonstrated activity in a heavily pre-treated patient population that includes post-asciminib patients, with a preli...

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