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The pivotal phase III, randomized ALFA-0701 study (NCT00927498) compared the safety and efficacy of induction therapy [DA] with daunorubicin (60 mg/m2 for 3 days) and cytarabine (200 mg/m2 for 7 days) plus fractionated doses of gemtuzumab ozogamicin (3 mg/m2 on days 1, 4, 7) versus DA alone in patients aged 50–70 years with treatment-naive acute myeloid leukemia (AML). Patients in complete remission (CR) were administered two consolidations courses of intermediate doses of cytarabine with or without one dose of gemtuzumab ozogamicin (3 mg/m2 on day 1, maximum dose: 5mg), according to initial randomization.
Two-hundred and eighty patients with untreated de novo AML were randomized 1:1 to receive DA plus gemtuzumab ozogamicin (GO arm, n = 140) or DA alone (control arm, n = 140). The primary endpoint of the study was event-free survival (EFS). Initial results at data cutoff of 1st August 2011, published in Lancet by Castaigne S. et al. in 2012, showed that the estimated 2-year EFS was significantly longer in patients in the GO arm compared to the control arm (40.8 vs 17.1 months respectively, HR = 0.58, P = 0.0003). Although, the CR rates were similar in patients between the GO and control arm as was the treatment-mortality rates.1
The final safety and efficacy data with a longer follow-up (data cutoff: 30th April, 2013) of the phase III randomized ALFA-0701 study was reported by Juliette Lambert from Centre Hospitalier de Versailles, Le Chesnay, France, and colleagues, in an article published in Haematologica on 3rd August, 2018.2 Of the 280 patients randomized in this study, data was reported for 271 patients (GO arm, n = 135; control arm, n = 136).
The authors concluded that the final results of the ALFA-0701 study demonstrate that fractionated doses of gemtuzumab ozogamicin added to standard chemotherapy significantly prolongs EFS in patients with previously untreated de novo AML and has an “acceptable safety profile”. This phase III study formed the basis of approval for gemtuzumab ozogamicin in Europe and the United States.
Updates from NCRI AML18 and AML 19 trials
During the 2nd National Cancer Research Institute (NCRI) acute myeloid leukemia (AML) Academy Meeting, Nigel Russell presented updated data on the ongoing NCRI AML18 and AML19 trials. Here, we are pleased to...
ASH 2018 | Clinical outcomes of patients with acute myeloid leukemia who underwent HSCT in the phase III ALFA-0701 study
Post-transplant outcomes observed in patients with AML treated with standard chemotherapy with and without GO were similar.
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