Enliven Therapeutics Inc. has recently unveiled promising early results from its Phase 1b ENABLE trial for ELVN-001, a novel treatment for chronic myeloid leukemia (CML). This news has generated considerable excitement within the biopharmaceutical sector, leading to a notable increase in the company's stock value. The trial focuses on patients whose condition has proven resistant or intolerant to existing tyrosine kinase inhibitors, highlighting the urgent need for new and effective therapeutic options.
Enliven Therapeutics' ELVN-001 Demonstrates Strong Efficacy and Safety in Leukemia Trial
On January 8, 2026, Enliven Therapeutics Inc. released initial data from its ongoing Phase 1b ENABLE trial for ELVN-001, a drug designed to treat chronic myeloid leukemia (CML). The clinical-stage biopharmaceutical company's announcement sparked a surge in its stock, with shares trading significantly higher than their average volume. The trial, targeting patients with relapsed, refractory, or intolerant CML to available tyrosine kinase inhibitors (TKIs), has shown encouraging outcomes.
As of December 22, 2025, the trial had enrolled 60 heavily pre-treated patients. In the 80 mg QD Phase 1b cohort, all 19 evaluable patients demonstrated notable efficacy within 24 weeks. The rates of major molecular response (MMR) achievement reached 38%, and deep molecular response (DMR) was observed in 16% of patients. These figures compare favorably to previous Phase 1 trials of approved BCR::ABL1 TKIs, including Novartis AG's Scemblix (asciminib).
Furthermore, in the randomized 60 mg and 120 mg cohorts, comprising 41 patients, even more impressive rates were reported: MMR achievement at 53% and DMR at 35%. Across all Phase 1b cohorts, every evaluable patient who had achieved MMR at enrollment either maintained or further deepened their response.
ELVN-001 also maintained a favorable safety and tolerability profile across all tested doses (60 mg to 120 mg QD), consistent with earlier findings. No maximum tolerated dose was reached, and no new safety concerns emerged, indicating a robust safety profile. The company is now planning to commence the ENABLE-2 Phase 3 trial for ELVN-001 in the latter half of 2026, marking a significant step towards potential market availability.
The positive interim data for ELVN-001 provides a beacon of hope for individuals suffering from chronic myeloid leukemia, particularly those who have exhausted conventional treatment avenues. The impressive efficacy and safety profiles observed in the Phase 1b trial underscore the potential for ELVN-001 to become a crucial new therapy, offering improved outcomes and a better quality of life. This development reinforces the critical importance of continued research and innovation in oncology, pushing the boundaries of what is possible in cancer treatment. The market's enthusiastic response to Enliven Therapeutics' announcement reflects not only investor confidence but also the broader scientific community's recognition of a promising advancement in the fight against leukemia.