Overall survival more than doubled at 5 years with VYXEOS (18%) vs 7+3a (8%) based on KM estimates1,2
Median overall survival (primary endpoint) of 9.6 months with VYXEOS vs 5.9 months with 7+3 (HR=0.69 [0.52, 0.90], P=0.005b)1
With median follow-up of 60 months, the improvement in OS was maintained with a stable hazard ratio2
Kaplan-Meier curve for overall survival, ITT population2
aCytarabine 100 mg/m2 and daunorubicin 60 mg/m2.1
bP value is 2-sided.1
Strive for higher remission rates in sAML with VYXEOS1,3
Almost half of sAML patients treated with VYXEOS achieved CR+CRi3
Percentage of sAML patients who achieved CR and CR+CRi1,3
For sAML patients whose treatment goals align with transplant, start with VYXEOS1
The goal of chemotherapy is to eliminate as many leukemia cells from the body as possible to achieve remission,5,6 and low leukemic burden impacts outcomes of HSCT7
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Exploratory post hoc analysis of patients who achieved CR or CRi and did not undergo transplant in the Phase 3 trial8,f
Median OS for non-HSCT
patients who achieved CR8
Median OS for non-HSCT
patients who achieved CR+CRi8
Limitations of subanalysis8
- This subgroup analysis was exploratory and not powered to determine statistical significance. No efficacy conclusions about OS following CR or CRi can be drawn from this analysis
- Results should be interpreted with caution, as this analysis was not prespecified and was conducted in a small, nonrandomized subgroup (n=61)8
- The treatment effect of this nonrandomized subgroup was possibly confounded by unbalanced baseline characteristics
fBased on primary analysis of median follow-up of 20.7 months.3
Exploratory post hoc analyses of 5-year OS in patients who received HSCT in the Phase 3 trial2
5-YEAR FOLLOW-UP
Analysis 1: Kaplan-Meier curve for overall survival landmarked from time of transplant, ITT population2
Median survival (95% CI)
VYXEOS: Not reached (n=25/53)
7+3: 10.3 months (6.2, 16.7) (n=30/39)
Limitations of subanalysis2
- This subgroup analysis was exploratory and not powered to determine statistical significance. No efficacy conclusions about OS following HSCT can be drawn from this analysis
- Results should be interpreted with caution, as this analysis was not prespecified and was conducted in a small, nonrandomized subgroup (n=92)2
- The treatment effect of this nonrandomized subgroup was possibly confounded by unbalanced baseline characteristics
- A higher proportion of patients proceeding to HSCT in the VYXEOS arm (77%) were in CR/CRi as compared with the 7+3 arm (62%)2
- To address this limitation, Analysis 2 (right)(below) evaluated only those patients in each treatment arm who were in CR/CRi at the time they received HSCT2
Analysis 2: Kaplan-Meier curve for overall survival landmarked from time of transplant in patients who achieved CR or CRi2
Median survival (95% CI)
VYXEOS: Not reached (n=19/41)
7+3: 11.7 months (4.6, 24.3) (n=17/24)
Limitations of subanalysis2
- This subgroup analysis was exploratory and not powered to determine statistical significance. No efficacy conclusions about OS following HSCT after CR or CRi can be drawn from this analysis
- Results should be interpreted with caution, as this analysis was not prespecified and was conducted in a small, nonrandomized subgroup (n=65)2
- The treatment effect of this nonrandomized subgroup was possibly confounded by unbalanced baseline characteristics
Discussion of the pivotal Phase 3 trial
Dr. Bayard Powell, section chief of Hematology and Oncology at Wake Forest Baptist Health, reviews the VYXEOS Phase 3 trial in detail and explains what the efficacy and safety data mean for adult sAML patients
Results of the Phase 3 trial were also published in the Journal of Clinical Oncology3
Study Design1,2
The Phase 3 study was a randomized, multicenter, open-label, active-controlled superiority study of VYXEOS (N=153) versus cytarabine and daunorubicin (7+3) (N=156) in patients 60 to 75 years of age with newly-diagnosed t-AML or AML-MRC (N=309). Efficacy was established on the basis of overall survival from the date of randomization to death from any cause.1
VYXEOS 44 mg/100 mg per m2 (daunorubicin/cytarabine) was given intravenously on Days 1, 3, and 5 for first induction and on Days 1 and 3 for those needing a second induction. For consolidation, the VYXEOS dose was 29 mg/65 mg per m2 (daunorubicin/cytarabine) on Days 1 and 3. In the 7+3 arm, first induction was cytarabine 100 mg/m2/day on Days 1-7 by continuous infusion + daunorubicin 60 mg/m2/day on Days 1-3. For second induction and consolidation, cytarabine was dosed on Days 1-5 and daunorubicin on Days 1 and 2. Patients could receive up to 2 cycles of induction and 2 cycles of consolidation in each arm. Subsequent induction was highly recommended for patients who did not achieve a response and was mandatory for patients achieving >50% reduction in percent blasts.1
A preplanned overall survival analysis was conducted based on the final 5-year follow-up results from the Phase 3 trial.2
Learn more about the Phase 3 study design