For treatment-eligible patients with newly diagnosed FLT3-ITD+ AML Start and stay with VANFLYTA—the only FLT3 inhibitor FDA-approved for use in INDUCTION, CONSOLIDATION, AND MAINTENANCE1-3*† *In patients without prior allogeneic HSCT. Please see Full Indication, including Limitations of Use, below.
QuANTUM-First is the only pivotal trial to specifically study patients with FLT3-ITD+ through induction, consolidation, and maintenance1-3†
- In QuANTUM-First, the efficacy and safety of VANFLYTA plus standard chemotherapy vs placebo plus standard chemotherapy were studied in a Phase 3, randomized, double-blind, placebo-controlled, multicenter global study of 539 patients with newly diagnosed FLT3-ITD+ AML. Patients were randomized to placebo (n=271) or VANFLYTA (n=268)1,4,5
- Patients were stratified by age (<60 vs ≥60 years), white blood cell count at diagnosis (<40x109/L vs ≥40x109/L), and region (North America, Europe vs Asia, other regions)1
Standard chemotherapy included cytarabine- and anthracycline-based induction (either daunorubicin or idarubicin) and consolidation regimens. Eligible patients, including those who underwent allogeneic HSCT, continued with single-agent VANFLYTA or standard chemotherapy. There was no re-randomization at the start of post-consolidation therapy.1,4
- Among the patients who entered maintenance, 64% completed at least 12 cycles, 36% completed at least 24 cycles, and 16% completed all 36 planned cycles of maintenance†
- 29% (157/539) of the patients underwent HSCT in first CR
A second course of induction was administered to 20% of the patients; 65% initiated at least 1 cycle of consolidation; and 39% initiated maintenance treatment with VANFLYTA.1†
†Limitations of Use: VANFLYTA is not indicated as maintenance monotherapy following allogeneic HSCT; improvement in overall survival with VANFLYTA in this setting has not been demonstrated.
‡Patients received 35.4 mg orally once daily on Days 8-21 of 7+3 (cytarabine [100 or 200 mg/m2/day] on Days 1-7 plus daunorubicin [60 mg/m2/day] or idarubicin [12 mg/m2/day] on Days 1-3), and on Days 8-21 or 6-19 of an optional second induction (7+3 or 5+2 [5 days cytarabine plus 2 days daunorubicin or idarubicin], respectively). During Cycle 2 of the Induction phase, VANFLYTA or placebo started on Day 8 or Day 6, depending on the chemotherapy regimen selected (7+3 or 5+2, respectively).1
§Randomization may be performed later, between Days 8-10, to address clinical concerns (eg, electrolyte abnormalities or QT prolongation).5
||Consolidation chemotherapy consisted of 35.4 mg orally once daily on Days 6-19 of high-dose cytarabine (1.5 to 3 g/m2 every 12 hours on Days 1, 3, and 5) for up to 4 cycles.1
VANFLYTA was studied in the largest and longest trial of patients with newly diagnosed FLT3-ITD+ AML1,4
BASELINE PATIENT CHARACTERISTICS4
- Studied in a wide range of ages, up to 75 years with 40% of patients over 60 years1,4
- Median age was 56 years (range, 20-75)
- Of the 539 randomized patients1:
- Of patients studied, the majority (72%) had intermediate-risk cytogenetics, and 65.5% had an ECOG performance status of 1 or over at baseline
- FLT3-ITD VAF was 3-25% in 36% of patients, >25-50% in 52% of patients, and >50% in 12% of patients
- NPM1 mutations were identified in 52% of patients
*Three patients in the ITT set were randomized but not treated in each arm.4
†One patient in the placebo group was missing an ECOG status.4
‡Favorable: inv(16), t(16;16), t(8;21), or t(15;17); intermediate: normal, 8, 6, or −Y; unfavorable: deI(5q), −5, del(7q), −7, or complex karyotype.4
VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)–positive as detected by an FDA-approved test.
†Limitations of Use: VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated.
AML=acute myeloid leukemia; CR=complete remission; CRc=composite complete remission; DoCR=duration of complete response; ECOG=Eastern Cooperative Oncology Group; EFS=event-free survival; FLT3=FMS (feline McDonough sarcoma)–like tyrosine kinase 3; HiDAC=high-dose cytarabine; HR=hazard ratio; HSCT=hematopoietic stem cell transplantation; ITF=induction treatment failure; ITD=internal tandem duplication; ITF=induction treatment failure; ITT=intent-to-treat; mRFS=median relapse-free survival; NCCN=National Comprehensive Cancer Network® (NCCN®); NE=not estimable; NPM1=nucleophosmin; OS=overall survival; REMS=Risk Evaluation and Mitigation Strategy; RFS=relapse-free survival; VAF=variant allelic frequency.
1. VANFLYTA [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2024. 2. XOSPATA [package insert]. Northbrook, IL: Astellas Pharma US, Inc; 2022. 3. RYDAPT [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2023. 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. Lancet. Published online: April 25, 2023. doi:10.1016/S0140-6736(23)00464-6 5. 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. Supplementary appendix. Lancet. Published online: April 25, 2023. doi.org/10.1016/S0140-6736(23)00464-6
In patients with newly diagnosed FLT3-ITD+ AML treated with VANFLYTA plus standard chemotherapy
VANFLYTA provided superior overall survival vs standard chemotherapy alone1,4
The study demonstrated a statistically significant improvement in OS for the VANFLYTA arm.1,4
PRIMARY ENDPOINT: OVERALL SURVIVAL IN VANFLYTA1
REDUCTION IN THE RISK OF
DEATH WITH VANFLYTA + STANDARD
CHEMOTHERAPY
vs placebo + standard chemotherapy
HR: 0.78‡
(95% CI: 0.62-0.98); P=0.03241§
†Limitations of Use: VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated.
‡Hazard ratio is based on stratified Cox proportional hazard model stratified by the stratified factors used in randomization.4
§P value was calculated using a stratified log-rank test.4
The primary analysis was conducted after a minimum follow-up of 24 months after the randomization of the last patient.1
Exploratory subgroup analysis of overall survival in patients who did not undergo allogeneic HSCT and received maintenance therapy5†
Overall Survival in Patients Who Received Maintenance Therapy† Without Allogeneic HSCT5
- This was an exploratory subgroup analysis of 43% of patients (89/208) who received maintenance therapy with VANFLYTA or placebo following consolidation chemotherapy. OS HR: 0.40 (95% Cl: 0.19-0.84)1
- ~60% (170/268) of patients who entered consolidation phase in the VANFLYTA arm did not get a transplant4
- Exploratory, subgroup analysis—interpret with caution. Not powered to detect statistical significance
Consider VANFLYTA for maintenance monotherapy† following consolidation
chemotherapy in adults with newly diagnosed FLT3-ITD+ AML1
†Limitations of Use: VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated.
Exploratory subgroup analysis of overall survival in patients who underwent allogeneic HSCT and received maintenance therapy5†
Overall Survival in Patients Who Received Maintenance Therapy† With Allogeneic HSCT5¶
- This was an exploratory subgroup analysis of 57% of patients (119/208) who received maintenance therapy with VANFLYTA or placebo following HSCT. OS HR: 1.62 (95% CI: 0.62-4.22)1
- Exploratory, subgroup analysis—interpret with caution. Not powered to detect statistical significance
†Limitations of Use: VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated.
¶Received protocol-specified allogeneic-HSCT.4
AML=acute myeloid leukemia; CI=confidence interval; CR=complete remission; CRc=composite complete remission; FLT3=FMS (feline McDonough sarcoma)–like tyrosine kinase 3; HR=hazard ratio; HSCT=hematopoietic stem cell transplantation; ITD=internal tandem duplication; NCCN=National Comprehensive Cancer Network® (NCCN®); OS=overall survival; REMS=Risk Evaluation and Mitigation Strategy; RFS=relapse-free survival.
1. VANFLYTA [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2024. 2. XOSPATA [package insert]. Northbrook, IL: Astellas Pharma US, Inc; 2022. 3. RYDAPT [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2023. 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. Lancet. Published online: April 25, 2023. doi:10.1016/S0140-6736(23)00464-6 5. Sekeres MA, Erba H, Montesinos P, et al. (2024, June 13-16). QuANTUM-First: efficacy in newly diagnosed patients with FMS-like tyrosine kinase 3-internal tandem duplication–positive acute myeloid leukemia who received continuation therapy [Oral presentation S142]. European Hematology Association 2024 Congress, Madrid, Spain. Accessed July 21, 2025. https://datasourcebydaiichisankyo.com/documents/20833/21562/EHA2024_Sekeres_Quiz%20QF%20Maintenance_Oral.pdf
VANFLYTA was studied for complete remission and composite complete remission1,5
SECONDARY ENDPOINTS1,5
Primary EFS analysis (with ITF defined as not achieving CR by Day 42 from the start 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]).4,5
- Since EFS was not statistically significant, formal hierarchical testing on other secondary endpoints, including CR and CRc, was stopped; their results are provided descriptively5
†Limitations of Use: VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated.
‡CRc is equal to complete remission (CR) + CR with incomplete neutrophil or platelet recovery (CRi) after induction.5
AML=acute myeloid leukemia; CI=confidence interval; CR=complete remission; CRc=composite complete remission; EFS=event-free survival; FLT3=FMS (feline McDonough sarcoma)–like tyrosine kinase 3; HR=hazard ratio; HSCT=hematopoietic stem cell transplantation; ITD=internal tandem duplication; ITF=induction treatment failure; NCCN=National Comprehensive Cancer Network® (NCCN®); REMS=Risk Evaluation and Mitigation Strategy; RFS=relapse-free survival.
1. VANFLYTA [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2024. 2. XOSPATA [package insert]. Northbrook, IL: Astellas Pharma US, Inc; 2022. 3. RYDAPT [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2023. 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. Lancet. Published online: April 25, 2023. doi:10.1016/S0140-6736(23)00464-6 5. 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
VANFLYTA duration of complete remission vs standard chemotherapy alone1
EXPLORATORY ENDPOINT: DURATION OF COMPLETE REMISSION1‡
†Limitations of Use: VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated.
‡By independent review committee.4
AML=acute myeloid leukemia; CI=confidence interval; CR=complete remission; CRc=composite complete remission; FLT3=FMS (feline McDonough sarcoma)–like tyrosine kinase 3; HSCT=hematopoietic stem cell transplantation; ITD=internal tandem duplication; NCCN=National Comprehensive Cancer Network® (NCCN®); NE=not estimable; REMS=Risk Evaluation and Mitigation Strategy; RFS=relapse-free survival.
1. VANFLYTA [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2024. 2. XOSPATA [package insert]. Northbrook, IL: Astellas Pharma US, Inc; 2022. 3. RYDAPT [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2023. 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. Lancet. Published online: April 25, 2023. doi:10.1016/S0140-6736(23)00464-6
VANFLYTA RFS rates in patients with a complete response vs standard chemotherapy alone4
EXPLORATORY ENDPOINT: RELAPSE-FREE SURVIVAL4‡
- 39% reduction in the risk of relapse or death vs placebo
+ standard chemotherapy; HR: 0.61 (95% CI:
0.44-0.8)4
- Analysis on RFS, which was a prespecified exploratory outcome, was not powered to detect a difference in treatment effect between the 2 arms. Cautious interpretation is recommended, and no conclusions can be drawn from these data
†Limitations of Use: VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated.
‡In patients who achieved CR by end of induction by IRC.4
AML=acute myeloid leukemia; CI=confidence interval; CR=complete remission; CRc=composite complete remission; FLT3=FMS (feline McDonough sarcoma)–like tyrosine kinase 3; HR=hazard ratio; HSCT=hematopoietic stem cell transplantation; IRC=independent review committee; ITD=internal tandem duplication; mRFS=median relapse-free survival; NCCN=National Comprehensive Cancer Network® (NCCN®); NE=not estimable; REMS=Risk Evaluation and Mitigation Strategy; RFS=relapse-free survival.
1. VANFLYTA [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2024. 2. XOSPATA [package insert]. Northbrook, IL: Astellas Pharma US, Inc; 2022. 3. RYDAPT [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2023. 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. Lancet. Published online: April 25, 2023. doi:10.1016/S0140-6736(23)00464-6
