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SECONDARY AML Arrow mechanism
of action Arrow Dosing Arrow
VYXEOS PHASE 3 STUDY

VYXEOS was evaluated in a Phase 3, multicenter, open-label, active-controlled, randomized (1:1) study of VYXEOS vs 7+3 in 309 patients with newly diagnosed sAML1

Patients in the Phase 3 study were aged 60-75 years, previously untreated, able to tolerate intensive chemotherapy, and had ECOG PS 0-2.1,10

  • Primary endpoint: OS
  • Median OS (primary analysis) of 9.6 months with VYXEOS vs 5.9 months with 7+3, reducing the risk of death by 31% (HR=0.69 [95% CI: 0.52, 0.90], P=0.005 [P value is 2-sided])
  • Additional endpoints in this study included remission rate (CR, CR + CRi), remission duration, and rate of HSCT
  • HSCT OS was an exploratory post hoc endpoint
Real-world evidence arrow
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When treating sAML,
transplant is the goal

VYXEOS can help more patients
reach HSCT10,11

The foundation of sAML treatment is
intensive chemotherapy, with the ultimate
goal of achieving remission
and reaching HSCT.2,8

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Overall rate of HSCT achieved with VYXEOS
vs 7+310,a chart

Data from the Phase 3 study showed that more
patients with
sAML reached HSCT with VYXEOS
vs 7+3.

Rate of HSCT during first CRb with VYXEOS
vs 7+31,11 chart

A greater proportion of patients with sAML who
achieved first CR
with VYXEOS subsequently
underwent HSCT vs 7+3.

aFirst CR, induction, failure, or as salvage after relapse.1 bFirst CR after 1 or 2 induction cycles.11
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HSCT OS | Exploratory
Post Hoc Analysis

Starting with VYXEOS
can lead to
prolonged
survival after HSCT10

More than double the 3-year OSa post HSCT for patients treated with VYXEOS (56%) vs 7+3 (23%).10

aBased on Kaplan-Meier estimates.
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Exploratory post hoc analysis

3-year OS post HSCT with VYXEOS vs 7+3

Analysis 1: OS landmarked from time of HSCT10
(KM estimated survival rates) chart chart
MEDIAN OS (95% CI)
VYXEOS: Not reached (16.2, NR) (n=23/53)
7+3: 10.3 months (6.2, 16.7) (n=30/39)
Analysis 2: OS landmarked from time
of HSCT in patients who achieved CR or CRi12
(KM estimated survival rates) chart chart
MEDIAN OS (95% CI)
VYXEOS: Not reached (15.6, NR) (n=19/41)
7+3: 11.7 months (4.6, 24.3) (n=17/24)
Scroll to view limitations
aNumber at risk.10,12
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Limitations of subanalyses
  • These exploratory post hoc subgroup analyses were not powered to determine statistical significance. No efficacy conclusions about OS following HSCT or OS following HSCT after CR or CRi can be drawn from these analyses
  • Results should be interpreted with caution, as these analyses were not prespecified and were conducted in small, nonrandomized subgroups (Analysis 1, n=92; Analysis 2, n=65)10
  • 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 (75%) were in CR/CRi as compared with the 7+3 arm (62%)10
    • To address this limitation, Analysis 2 evaluated only those patients in each treatment arm who were in CR/CRi at the time they received HSCT12

View more VYXEOS clinical data

Clinical Brochure icon
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CLINICAL DATA: SAFETY

Comparable safety to 7+3

The safety profile of VYXEOS in the Phase 3 study was found to be comparable to 7+3.13

Click on the cards below to learn more.

Adverse
Reactions Arrow Mortality Arrow Cardiotoxicity Arrow