The P-III (QuANTUM-First) study evaluated quizartinib + CT vs CT alone in a ratio (1:1) in 539 patients aged 18-75yrs. with FLT3-ITD+ AML at 193 sites across Asia, EU, North & South America & Oceania
The results showed OS benefits with m-OS (31.9mos. vs 15.1mos.) after a median follow-up of 39.2mos., 22.4% reduction in risk of death & the safety profile was manageable with no new safety signals, rates of TEAEs associated with fatal outcomes (11.3% vs 9.7%)
0.8% discontinued treatment due to QT prolongation, 0.8% experienced cardiac arrest with V-fib on ECG, CRc rate (71.6% vs 64.9%), rates of CR (54.9% vs 55.4%), the median duration of CR (38.6mos. vs 12.4mos.), m-RFS (39.3mos vs 13.6mos.) with 38.7% relative risk reduction of relapse or death
Ref: Businesswire Image: Daiichi Sankyo
