Blinded results from Part A of the phase 2b/3 MIRACLE trial showed encouraging activity for Annamycin combined with Cytarabine in patients with relapsed or refractory Acute Myeloid Leukemia receiving second-line treatment. The study compared the combination with cytarabine plus placebo in patients aged 18 to 80.
Among 45 evaluable patients, the pooled composite complete remission rate exceeded 40%, while the complete remission rate was about 30%. These early outcomes compare favorably with historical remission rates of 17% to 18% reported for cytarabine alone. More than 30% of enrolled patients had previously failed venetoclax-based therapy, and the median patient age was in the mid-60s.
Annamycin has received FDA Fast Track and Orphan Drug designations for relapsed or refractory AML. The trial is testing two annamycin dose levels to identify the optimal regimen before moving into a direct comparison stage. Unblinded efficacy data from the first 45 patients are expected before June 30, 2026, with full Part A enrollment projected in the third quarter of 2026.