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Gemtuzumab Ozogamicin Misses Early EFS Endpoint, as Phase III Study Continues in NPM1+ AML

Brittany Cote
Published: Wednesday, Feb 26, 2020

blood cellsD Gemtuzumab ozogamicin (Mylotarg) in combination with intensive induction therapy was associated with a higher early death rate compared with induction therapy alone in patients with NPM1-mutated acute myeloid leukemia (AML), according to results of the phase III AMLSG 09-09 trial.

However, patients who achieved complete remission (CR) or incomplete hematologic recovery (CRi) after induction therapy experienced fewer relapses in the gemtuzumab ozogamicin arm compared with the standard-of-care arm, which comprised idarubicin, cytarabine, etoposide, and all-trans-retinoic acid (ATRA).

Event-free survival (EFS) in the gemtuzumab ozogamicin arm was not significantly different compared with the standard arm (HR, 0.83; 95% CI, 0.65-1.04; P = .10). The early death rate during induction therapy was 10.3% in the gemtuzumab ozogamicin arm and 5.7% in the standard arm (P = .05). The causes of death in both arms were mainly due to infections.

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