First chemotherapy to demonstrate superior overall survival vs 7+3a in adults with newly-diagnosed t-AML or AML-MRC1

Superior overall survival compared to 7+31

Kaplan-Meier curve for overall survival, ITT population1

Vyxeos Kaplan-Meier curve

Study Design1
The Phase 3 study was a randomized, multicenter, open-label, active-controlled superiority study of VYXEOS versus cytarabine and daunorubicin (7+3) in patients 60 to 75 years of age with newly-diagnosed t-AML or AML-MRC. There were 153 patients randomized to VYXEOS and 156 patients randomized to the 7+3 arm. 20% had t-AML, 54% had AML with an antecedent hematological disorder, and 25% had de novo AML with MDS-related cytogenetic abnormalities. Efficacy was established on the basis of overall survival from the date of randomization to death from any cause.

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.

Learn more about the Phase 3 study design.

  1. Cytarabine and daunorubicin.

Statistically significant improvement in CR vs 7+31

Percentage of patients who achieved CR1

Vyxeos CR endpoint
  1. Cytarabine and daunorubicin.

More patients received an HSCT after VYXEOS1

Overall rate of HSCT1,b

Vyxeos HSCT endpoint
  1. Cytarabine and daunorubicin.
  2. Induction failure, first CR, or as salvage after relapse.
  • The rate of HSCT in first CR was 20% in the VYXEOS arm and 12% in the control arm