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Promising Results from Enliven Therapeutics' Phase 1 Trial of ELVN-001

Enliven Therapeutics, Inc., a clinical-stage biopharmaceutical firm based in Boulder, Colorado, recently presented updated data from its ongoing Phase 1 ENABLE clinical trial evaluating ELVN-001, a treatment for chronic myeloid leukemia (CML), during the European Hematology Association (EHA) Congress 2025 held from June 12-15 in Milan, Italy. This study reveals encouraging clinical outcomes that may propel ELVN-001 as a new therapeutic option for patients suffering from this challenging condition.

Background on CML and Treatment Goals

Chronic myeloid leukemia (CML) is a type of cancer that affects the blood and bone marrow, and its treatment landscape has evolved significantly with the success of targeted therapies known as tyrosine kinase inhibitors (TKIs). These advancements have transformed CML from a life-threatening condition to one where patients can enjoy a near-normal life expectancy. Consequently, the objectives for treatment have increasingly focused on not only response rates but also quality of life and tolerability for this chronic illness.

Dr. Andreas Hochhaus, a notable hematology expert at Jena University Hospital in Germany, expressed optimism regarding the data from ELVN-001 during its presentation. He highlighted that while TKIs have substantially improved patient outcomes, unmet needs persist—particularly concerning treatment resistance and intolerance. The positive results from this trial are particularly notable given that the patient cohort was heavily pretreated with multiple drugs prior to enrollment.

Key Findings from the ENABLE Study

The ENABLE trial has enrolled 90 patients at various dosing levels, with dosages ranging from 10 mg to 80 mg. The median duration of treatment as of the latest cutoff date was approximately 29 weeks. As for the trial's results:

• - A cumulative major molecular response (MMR) rate of 47% was reported, with 32% of evaluable patients achieving MMR by 24 weeks.
• - Among those who had resistance to their last TKIs, 41% were in MMR by the 24-week mark. This achievement is particularly significant given the prior treatments these patients had undergone, which included asciminib and ponatinib.
• - Safety data indicated that ELVN-001 was well tolerated across all evaluated doses, with low rates of dose modifications and discontinuations due to adverse events.

Safety and Tolerability Profile of ELVN-001

An important aspect of any new therapy in oncology is its safety profile. The data from the ENABLE trial shows that:

• - Only a small percentage (3.4%) of patients experienced dose reductions due to treatment-emergent adverse events (TEAEs), and just 4.6% discontinued the treatment because of TEAEs.
• - Most TEAEs were mild and occurred infrequently, with no reports of enhanced cardiovascular toxicity. The maximum tolerated dose has yet to be reached, indicating a potentially favorable therapeutic window.

The Future of ELVN-001

As the trial progresses, the consistency in cumulative and achieved MMR rates has encouraged the Enliven team. Dr. Helen Collins, Chief Medical Officer at Enliven, shared her enthusiasm regarding the potential of ELVN-001 to become a best-in-class option for those living with CML. "We believe that the favorable safety and tolerability insights, along with robust efficacy, could establish ELVN-001 as a significant advancement in the treatment protocol for CML," Collins stated.

The goal is to move toward pivotal trials, with plans to initiate a head-to-head Phase 3 trial by 2026. This strategic planning is buoyed by historical data indicating potential success in subsequent major trials based on early Phase 1 results.

Conclusion

Enliven Therapeutics' ELVN-001 embodies promise for patients contending with chronic myeloid leukemia, especially those who have not responded well to existing therapies. The results presented at EHA 2025 stress an evolving narrative in CML treatment that aims for not only longer life but improved living quality. As further studies unfold, the advancements in CML management through new therapeutic options like ELVN-001 hold hope for many facing this difficult diagnosis.