Phase 3 trial in adults with newly-diagnosed t-AML or AML-MRC

Phase 3 study was a multicenter, open-label, active-controlled, randomized trial of VYXEOS vs 7+3 (cytarabine and daunorubicin) in 309 AML patients (aged 60-75)1,2

Key eligibility

Previously untreated

Aged 60-75

Able to tolerate intensive therapy

PS 0-2

Primary endpoint

Overall survival

309 patients total

  • Subsequent induction was recommended for patients who did not achieve a response and was mandatory for patients achieving >50% reduction in percent blasts
  • Post-remission therapy with HSCT was permitted either in place of or after consolidation chemotherapy