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

Kaplan-Meier curve for overall survival, ITT population

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. Twenty percent 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. Patients could receive up to 2 cycles of induction and 2 cycles of consolidation in each arm. Subsequent induction was recommended for patients who did not achieve a response and was mandatory for patients achieving >50% reduction in percent blasts.

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

Percentage of patients who achieved complete remission
  1. Cytarabine and daunorubicin.

More patients received an HSCT after VYXEOS1

Overall rate of HSCT1,b

Patients receiving stem cell transplant, Phase 3 trial
  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