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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

New
5-Year Follow-Up

Kaplan-Meier curve for overall survival, ITT population2

VYXEOS overall survival KM curve
1-Year KM-estimated survival3
VYXEOS: 42% 7+3: 28%
5-Year KM-estimated survival2
VYXEOS: 18% 7+3: 8%

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

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

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

OS from time of HSCT after treatment with VYXEOS

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

OS in from time of HSCT in CR/CRi patients who received VYXEOS

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

INDICATION

VYXEOS (daunorubicin and cytarabine) liposome for injection 44 mg/100 mg is indicated for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

IMPORTANT SAFETY INFORMATION

INDICATION

VYXEOS (daunorubicin and cytarabine) liposome for injection 44 mg/100 mg is indicated for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

Important Safety Information

WARNING: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTS

VYXEOS has different dosage recommendations than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection. Verify drug name and dose prior to preparation and administration to avoid dosing errors.