Mylotarg gemtuzumab ozogamicin: Phase III data

The open-label, French Phase III ALFA 0701 trial in 271 evaluable patients aged 50-70 with newly diagnosed AML showed that Mylotarg plus daunorubicin and cytarabine met the primary endpoint of EFS vs. daunorubicin and cytarabine alone at 2 years of follow-up (41.4% vs. 15.6%, p=0.0018). Mylotarg plus chemotherapy also met the secondary endpoints of median OS (34 vs. 19 months) and 2-year DFS vs. chemotherapy alone (48.5% vs. 18.1%, p=0.0009). Additionally, Mylotarg plus chemotherapy led to a non-significantly greater rate of complete remission (CR) or complete remission with incomplete platelet recovery (CRp) vs. chemotherapy alone (80% vs. 75%, p=0.31). Prolonged >=grade 3 thrombocytopenia was observed in 19 patients receiving Mylotarg, as well as 3 cases of liver veno-occlusive disease (VOD) or sinusoidal obstructive syndrome, 2 of which were fatal. There were no differences in the incidence of severe sepsis or the rate of ICU admission between treatment groups, with no significant difference in the rate of fatal adverse events possibly attributable to treatment (8.7% vs. 6.7%, p=0.65). The trial was sponsored by the Acute Leukemia French Association. Data were presented at the American Society of Hematology meeting in San Diego. ...