CPX-351: Phase IIb data

The open-label, international Phase IIb CLTR0308-205 trial in 125 patients aged 18-65 years with AML in first relapse showed that CPX-351 produced a 1-year OS rate, the primary endpoint, of 36% vs. 27% for intensive salvage therapy. On secondary endpoints, CPX-351 led to a median OS and EFS of 8.5 and 4 months, respectively, vs. 6.3 and 1.4 months for salvage therapy. Additionally, rates of CR or CR with incomplete blood count recovery (CRi) were 51% for CPX-351 vs. 41% for salvage therapy. Furthermore, the 90-day mortality rate was lower for CPX-351 vs. salvage therapy (19% vs. 30%). In a subgroup of patients with unfavorable European Prognostic Index (EPI) scores (n=85), CPX-351 significantly improved OS vs. salvage therapy (6.6 vs. 4.2 months, p=0.02). Patients received CPX-351 given as a 90-minute infusion on days 1, 3 and 5, or Intensive salvage therapies, including cytarabine alone or in combination with daunorubicin or mitoxantrone plus etoposide. Data were presented at the American Society of Hematology meeting in San Diego. ...