Investor Presentaiton
Quizartinib
QUANTUM-First study data
EHA 2022 Highlights (Presidential Symposium)
Daiichi-Sankyo
Quizartinib + SOC doubled OS in patients with AML 1L with FLT3-ITD mutation
vs SOC, regulatory submission planned in FY2022 H1 in JP/US/EU
Overall survival probability
1.0
0.8
0.6
Placeboc
Primary Endpoint: OS
0.4
MOS: 15.1 mo
AMOS: 16.8 mo
0.2
L
HR, 0.776
(95% CI, 0.615-0.979)
P=.0324 (2-sided) a
Quizartinibb
MOS: 31.9 mo
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0.0
T
T
T
0
3
6
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15
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27
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48
51
54
57
60
Time, months
QUANTUM-First study
Ph3 study for patients with newly
diagnosed AML with FLT3-ITD mutation
■Efficacy and safety were evaluated in
quizartinib + standard chemotherapy
arm and placebo + standard
chemotherapy arm
■Quizartinib demonstrated a 22.4%
reduction in the risk of death
compared to standard chemotherapy
alone
■Median OS of 31.9m compared to
15.1m with chemotherapy
■No new safety signals were observed
a P value was calculated using a stratified log-rank test. b Median follow-up time for quizartinib arm, 39.2 months. c Median follow-up time for placebo arm, 39.2 months.
AML: acute myeloid leukemia, OS: overall survival, SOC: standard of care
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