Phase III QUAZAR AML-001 visual abstract
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Despite reasonable initial responses with standard induction chemotherapy in elderly patients with acute myeloid leukemia (AML), approximately 80–90% of patients eventually relapse. In patients with AML, the duration of first remission is positively associated with favorable survival, and so it becomes crucial to prolong remission and prevent early relapse using post-remission therapy. Hematopoietic stem cell transplantation (HSCT) is often used as a potentially curative option following induction chemotherapy, however, older patients with AML are not always eligible for such intensive approaches.
Effective AML maintenance therapies are required when HSCT is not feasible and should reduce the risk of relapse while maintaining patient health-related quality of life. The oral formulation of azacitidine, CC-486, was approved as a maintenance therapy by the U.S Food and Drug Administration (FDA) in September 2020. The approval was based on the results of the phase III QUAZAR AML-001 trial (NCT01757535), evaluating maintenance with CC-486 vs placebo in patients aged ≥ 55 years with AML in first remission. Topline results showed that maintenance with CC-486 resulted in significantly improved overall survival (OS; the primary endpoint) and relapse-free survival (RFS; a secondary endpoint) vs placebo in the elderly AML setting.
Results from the follow-up of the QUAZAR AML-001 trial were presented at the 61st American Society of Hematology (ASH) Meeting and Exposition in 2019, and have since been published by Andrew Wei and colleagues in The New England Journal of Medicine.1 Read the AML Hub summary here, which highlights the clinically significant improvements in OS and RFS for patients in first remission receiving CC-486 as a maintenance therapy. The AML Hub is happy to provide a visual abstract of the QUAZAR AML-001 study.
FDA grants CC-486 priority review for the treatment of adult patients with AML
On May 1, 2020, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) and granted priority review to CC-486, an oral formulation of the...
QUAZAR AML-001 | Updates from EHA 2020
The QUAZAR AML-001 study (NCT01757535) has uncovered the significant clinical activity of CC-486 maintenance in patients aged ≥ 55 with acute myeloid leukemia (AML), in first remission following induction...
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