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Summary  This phase 2 study ( N  =   116) evaluated single‐agent vosaroxin, a first‐in‐class anticancer quinolone derivative, in patients ≥60 years of age with previously untreated unfavourable prognosis acute myeloid leukaemia. Dose regimen optimization was explored in sequential cohorts ( A : 72 mg/m 2  d 1, 8, 15;  B : 72 mg/m 2  d 1, 8;  C : 72 mg/m 2  or 90 mg/m 2  d 1, 4). The primary endpoint was combined complete remission rate (complete remission [ CR ] plus  CR  with incomplete platelet recovery [ CR p]). Common (>20%) grade ≥3 adverse events were thrombocytopenia, febrile neutropenia, anaemia, neutropenia, sepsis, pneumonia, stomatitis and hypokalaemia. Overall  CR  and  CR / CR p rates were 29% and 32%; median overall survival ( OS ) was 7·0 months; 1‐year  OS  was 34%. Schedule  C  (72 mg/m 2 ) had the most favourable safety and efficacy profile, with faster haematological recovery (median 27 d) and lowest incidence of aggregate sepsis (24%) and 30‐d (7%) and 60‐d (17%) all‐cause mortality; at this dose and schedule,  CR  and  CR / CR p rates were 31% and 35%, median  OS  was 7·7 months and 1‐year  OS  was 38%. Overall, vosaroxin resulted in low early mortality and an encouraging response rate; vosaroxin 72 mg/m 2  d 1, 4 is recommended for further study in this population. Registered at  www.clinicaltrials.gov : # NCT 00607997.

REVEAL ‐1, a phase 2 dose regimen optimization study of vosaroxin in older poor‐risk patients with previously untreated acute myeloid leukaemia