VANFLYTA(quizartinib)
efficacy data from the QuANTUM-First clinical trial
VANFLYTA + standard chemotherapy demonstrated a 22% reduced risk of death vs placebo + standard chemotherapy1
VANFLYTA in addition to standard chemotherapy provided superior overall survival vs placebo + standard chemotherapy.1,2*
PRIMARY ENDPOINT: OVERALL SURVIVAL WITH VANFLYTA1,2
Adapted from Erba, et al. 20231
In patients receiving VANFLYTA + standard chemotherapy, median OS was statistically significant at 31.9 months (95% CI: 21.0–NE) vs 15.1 months (95% CI: 13.2–26.2) in patients receiving placebo + standard chemotherapy [HR=0.78; (95% CI: 0.62–0.98); p=0.032†].1‡
The primary analysis was conducted after a minimum follow-up of 24 months after randomisation of the last patient.1
*Hazard ratio is based on stratified Cox proportional hazard model by the stratified factors used in randomisation.1
†p value was calculated using a two-sided stratified log-rank test.2
‡Analysis from the ITT population.1
VANFLYTA was studied for event-free survival, complete remission and composite complete remission1,3
SECONDARY ENDPOINTS: EVENT-FREE SURVIVAL, COMPLETE REMISSION AND COMPOSITE COMPLETE REMISSION1,3
Primary EFS analysis* (with ITF defined as not achieving CR by Day 42 of the last induction cycle) did not demonstrate a statistical significance between the two study arms [HR=0.92; (95% CI: 0.75–1.11); p=0.24†].3
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Parameter |
VANFLYTA + standard |
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CR |
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CRc‡ |
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VANFLYTA + standard chemotherapy extended relapse-free survival
vs placebo + standard chemotherapy1
*Since EFS was not statistically significant, formal hierarchical testing on other secondary endpoints was stopped; their results are provided descriptively.1
†p value was calculated using a stratified log-rank test.3
‡CRc is defined as complete remission or complete remission with incomplete neutrophil or platelet recovery.1
VANFLYTA + standard chemotherapy provided an additional 26 months duration of complete remission vs placebo +standard chemotherapy1
EXPLORATORY ENDPOINT: DURATION OF COMPLETE REMISSION1*
Adapted from Erba, et al. 20231
*By independent review committee.1
VANFLYTA RFS rates in patients with a complete response vs standard chemotherapy alone1
EXPLORATORY ENDPOINT: RELAPSE-FREE SURVIVAL1*
Adapted from Erba, et al. 2023 1,3
*In patients who achieved CR by end of induction by IRC.1