VANFLYTA efficacy data

QuANTUM-First is a Phase 3, randomized, double-blind, placebo-controlled study of 539 patients, ages 18-75, with newly diagnosed FLT3-ITD+ AML. Patients were randomized to VANFLYTA plus chemotherapy (N=268) or placebo plus chemotherapy (N=271). Primary endpoint was overall survival.1

For patients with newly diagnosed AML with the aggressive FLT3-ITD mutation2

VANFLYTA provided superior overall survival vs standard chemotherapy alone1

PRIMARY ENDPOINT: OVERALL SURVIVAL IN VANFLYTA1,3

KM curve chart showing the overall survival percentage with VANFLYTA + standard chemotherapy and Placebo + standard chemotherapy Swipe to the left KM curve chart showing the overall survival percentage with VANFLYTA + standard chemotherapy and Placebo + standard chemotherapy
KM curve chart showing the overall survival percentage with VANFLYTA + standard chemotherapy and Placebo + standard chemotherapy HR: 0.78* (95% CI: 0.62-0.98); P=0.0324
KM curve chart showing the overall survival percentage with VANFLYTA + standard chemotherapy and Placebo + standard chemotherapy
22%

Reduction in the risk of death with VANFLYTA + standard chemotherapy vs placebo + standard chemotherapy1

  • In an exploratory subgroup analysis of 43% of patients (89/208) who received maintenance therapy with VANFLYTA or placebo following consolidation chemotherapy, the OS HR was 0.40 (95% CI: 0.19-0.84). Of 57% of patients (119/208) who received maintenance therapy with VANFLYTA or placebo following HSCT, the OS HR was 1.62 (95% CI: 0.62-4.22)1

*Hazard ratio is based on stratified Cox proportional hazard model stratified by the stratified factors used in randomization.3

P value was calculated using a stratified log-rank test.3

The primary analysis was conducted after a minimum follow-up of 24 months after the randomization of the last patient.1

CI=confidence interval; HR=hazard ratio.

For patients with newly diagnosed AML with the aggressive FLT3-ITD mutation2

VANFLYTA was studied for complete remission and composite complete remission1,4

Secondary Endpoints1,4

Chart showing the secondary endpoints of VANFLYTA Swipe to the left
Chart showing the secondary endpoints of VANFLYTA

Primary EFS analysis* (with ITF defined as not achieving CR by Day 42 of the last induction cycle) did not show a statistical significance between the 2 study arms (HR=0.916 [95% CI=0.75-1.11]).3

*Since EFS was not statistically significant, formal hierarchical testing on other secondary endpoints was stopped; their results are provided descriptively.3

ITF=induction treatment failure.

For patients with newly diagnosed AML with the aggressive FLT3-ITD mutation2

VANFLYTA duration of complete remission vs standard chemotherapy alone1

EXPLORATORY ENDPOINT: Duration of Complete Remission1*

Image showing median duration of complete remission with VANFLYTA (38.6 months) versus median duration of complete remission with standard chemotherapy alone (12.4 months)Image showing median duration of complete remission with VANFLYTA (38.6 months) versus median duration of complete remission with standard chemotherapy alone (12.4 months)

*By independent review committee.3

NE=not estimable.

For patients with newly diagnosed AML with the aggressive FLT3-ITD mutation2

VANFLYTA RFS rates in patients with a complete response vs standard chemotherapy alone3

Exploratory Endpoint: Relapse-Free Survival3*

Chart showing VANFLYTA relapse-free survival rates in patients with a complete response vs standard chemotherapy alone Swipe to the left
Chart showing VANFLYTA relapse-free survival rates in patients with a complete response vs standard chemotherapy alone
Chart showing VANFLYTA relapse-free survival rates in patients with a complete response vs standard chemotherapy alone HR: 0.61 (95% CI: 0.44-0.85)
Chart showing VANFLYTA relapse-free survival rates in patients with a complete response vs standard chemotherapy alone

39% reduction in the risk of relapse or death
vs placebo + standard chemotherapy alone3

39% reduction in the
risk of relapse or death

vs placebo + standard chemotherapy alone3

*In patients who achieved CR by end of induction by IRC.3

IRC=independent review committee; mRFS=median relapse-free survival.

References:

1. VANFLYTA [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2023. 2. Daver N, Schlenk RF, Russell NH, Levis MJ. Targeting FLT3 mutations in AML: review of current knowledge and evidence. Leukemia. 2019;33:299-312. doi:10.1038/s41375-018-0357-9 3. Erba HP, Montesinos P, Kim H-J, et al. Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023;401(10388):1571-1583. doi:10.1016/S0140-6736(23)00464-6. 4. Erba HP, Montesinos P, Kim HJ, et al. Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial. Supplementary appendix. Lancet. Published online: April 25, 2023. doi:10.1016/S0140-6736(23)00464-6 5. XOSPATA [package insert]. Northbrook, IL: Astellas Pharma US, Inc; 2023. 6. RYDAPT [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021.