The AnnAraC combination of annamycin and cytarabine demonstrated encouraging activity in AML patients in the phase 1/2 MB-106 trial, suggesting potential survival benefits. Across first- through seventh-line settings, the median overall survival (OS) was nine months in the 22-patient intention-to-treat population. Patients achieving complete remission (CR, n=8) had a median OS of 15 months, with four still alive at study end. In the second-line setting (n=9), median OS reached 12 months.
Efficacy was notable, with a 36% CR rate overall and 50% in second-line patients. Median CR duration was 10 months, and half of the CR patients proceeded to curative bone marrow transplantation, considered a key goal in AML therapy.
MB-106 enrolled adults with treatment-naive or relapsed/refractory AML, administering liposomal annamycin for three days plus cytarabine for five days in 21-day cycles. These results support the phase 2B/3 MIRACLE trial (NCT05319587) aiming for second-line AML approval, with part A recruiting 45 patients and unblinding safety and efficacy data planned by year-end.