Enliven Therapeutics Reports Positive Results in Phase 1 Study

By Hao Liu • Thursday, June 11 13:03 • Permanent Link

Enliven Therapeutics said its phase 1 ENABLE study of ELVN-001 in previously treated chronic myeloid leukemia has now enrolled 161 patients, up from the earlier phase 1a/1b disclosure, with a median treatment duration of 35 weeks and 76% of patients still on study.

The company said 70% of enrolled patients had received at least three prior unique TKIs and 23% had received five or more. Prior asciminib exposure was reported in 62% of patients; among those patients, 93% had received three or more prior TKIs and 34% had received five or more.

By 24 weeks, major molecular response in the overall phase 1b group reached 54% among 69 evaluable patients, while the 80 mg once-daily cohort posted a 61% overall MMR rate among 28 evaluable patients. The company also said 40% of evaluable phase 1b patients had achieved MMR by 24 weeks, compared with 48% in the 80 mg cohort. Among patients who had already achieved MMR, 100% maintained it in both the overall phase 1b group and the 80 mg cohort.

Deep molecular response rates by 24 weeks were 22% in the overall phase 1b group and 30% in the 80 mg once-daily cohort.

Response rates varied by prior treatment burden. In the phase 1b group, patients with one or two prior TKIs had a 55% response rate by 24 weeks, compared with 32% for those with three to four prior TKIs and 29% for those with five or more. In the post-asciminib subgroup, the respective rates were 60%, 28% and 29%.

Safety data showed 6% of patients discontinued because of adverse events. Grade 3 or higher treatment-emergent adverse events were reported in 53 of 158 patients, or 34%, overall. The most common were thrombocytopenia, neutropenia and lipase elevation, each at 6%. At the 80 mg once-daily dose, grade 3 or higher events were reported in 15 of 62 patients, or 24%, with thrombocytopenia the only grade 3 or higher event seen in more than 5% of patients.

Following its end-of-phase 1 meeting with the FDA, Enliven said the agency aligned on 80 mg once daily as the recommended phase 3 dose and on a phase 3 ENABLE-2 population of patients previously treated with at least one TKI. The planned pivotal trial is expected to begin in the second half of 2026. Today the company's shares have moved 10.03% to a price of $40.71. If you want to know more, read the company's complete 8-K report here.

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