CC-486 is safe and well-tolerated as maintenance therapy in elderly patients ($75 years) with acute myeloid leukemia (AML) in first remission following induction chemotherapy: Results from the phase III QUAZAR AML-001 trial.
Abstract No : 7530
Abstract Type : Poster Discussion Session
Indication : Acute Myeloid Leukemia
Intervention : CC-486
Company : BMS
Technology : Small molecule
469 pts (>99% of all enrolled pts) were evaluable for safety (CC-486 n = 236; PBO n = 233). Median age was 68 yrs (range 55-86). Age distribution was similar between the two Tx arms (Table). Between Tx arms, AE rates within each age stratum were similar to rates in the overall study population. The most common AEs (any grade) with CC-486 were GI events, which were more frequent than in the PBO arm across age groups. Within the CC-486 arm, AE rates were generally consistent across age groups, except for constipation, which was > 20% more frequent in pts aged ≥ 75 yrs, and thrombocytopenia, which was ≥ 20% less frequent in this group (Table). Overall, 13% and 4% of pts in the CC-486 and PBO groups discontinued Tx due to AEs.
In QUAZAR AML-001, CC-486 was generally well tolerated in all age groups, including elderly pts aged ≥ 75 yrs.
CC-486 improves survival (mOS 24.8 mos) and delays relapse (mRFS 10.2 mos) in older patients in R/R AML.