The FDA ( Food and Drug Administration ) has approved Azacitidine tablets ( Onureg ) for continued treatment of patients with acute myeloid leukemia who achieved first complete remission ( CR ) or complete remission with incomplete blood count recovery ( CRi ) following intensive induction chemotherapy and are not able to complete intensive curative therapy.
Efficacy was investigated in QUAZAR, a multicenter, randomized, double-blind, placebo-controlled trial.
Patients ( n=472 ) who achieved CR or CRi with intensive induction chemotherapy with or without receiving subsequent 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 cycle.
The main efficacy outcome measure was overall survival ( OS ).
Median overall survival was 24.7 months ( 95% CI: 18.7, 30.5 ) in the Onureg arm and 14.8 months ( 95% CI: 11.7, 17.6 ) in the placebo arm ( hazard ratio, HR 0.69; 95% CI: 0.55, 0.86; p=0.0009 ).
A subgroup analysis showed consistency in the OS benefit for patients in either complete remission or complete remission with incomplete blood count recovery.
Adverse reactions in greater than or equal to 10% patients receiving Onureg were nausea, vomiting, diarrhea, fatigue / asthenia, constipation, pneumonia, abdominal pain, arthralgia, decreased appetite, febrile neutropenia, dizziness, and pain in extremity.
The recommended Onureg dose is 300 mg orally once daily with or without food on days 1 through 14 of each 28-day cycle. Continue Onureg until disease progression or unacceptable toxicity. ( Xagena )
Source: FDA, 2020