Oral AML Treatment That Demonstrated
Over 2 years median overall survival1*
There’s something you don’t see every day
The efficacy of ONUREG® was evaluated in QUAZAR® AML-001, a multicenter, randomized, double-blind, placebo-controlled, phase III study. Eligible patients were ages 55 years or older, had AML, and were within 4 months of achieving first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) with intensive induction chemotherapy. A total of 472 patients who completed induction with or without consolidation therapy were randomized 1:1 to receive ONUREG® 300 mg (n=238) or placebo (n=234) orally on Days 1 to 14 of each 28-day treatment cycle. Efficacy was established on the basis of overall survival (OS). The trial demonstrated a statistically significant improvement in OS for patients randomized to ONUREG® compared with placebo. In the trial, ONUREG® showed a median OS of 24.7 months (95% CI: 18.7, 30.5) vs 14.8 months (95% CI: 11.7, 17.6) for patients receiving placebo (HR 0.69 [95% CI: 0.55, 0.86; P=0.0009]).
AML, acute myeloid leukemia; CBF, core binding factor; CI, confidence interval; HCT, hematopoietic cell transplantation; HR, hazard ratio; MRD, minimal residual disease.
†≥60 with no specifications and <60 years old with intermediate-risk cytogenetics and/or molecular abnormalities, including MRD-positive (category 2B) or treatment-related disease other than CBF and/or unfavorable cytogenetics and/or molecular abnormalities.
‡This is not intended to replace consolidation chemotherapy, which can be curative in some cases. In addition, fit patients with intermediate- and/or adverse-risk cytogenetics may benefit from HCT in first CR, and there are no data to suggest that post-remission therapy with oral azacitidine can replace HCT. The panel also notes that the trial did not include younger patients or those with CBF-AML; it was restricted to patients ≥55 years of age with intermediate or adverse cytogenetics who were not felt to be candidates for HCT. Most patients received at least 1 cycle of consolidation prior to starting oral azacitidine.
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