Posted: Sunday, March 1, 2020
When gemtuzumab ozogamicin is added to induction therapy, patients with acute myeloid leukemia (AML) and a mutation in NPM1 tend to have fewer relapses if they achieve complete remission or complete remission with incomplete hematologic recovery, according to AMLSG 09-09 phase III trial findings. However, the trial did not meet its early primary endpoint of event-free survival. These findings were published in the Journal of Clinical Oncology by Richard F. Schlenk, MD, of the University Hospital of Ulm, Germany, and colleagues.
Patients with NPM-mutated AML eligible for intensive therapy were recruited for this study between May 2010 and September 2017. A total of 588 patients were randomly assigned to receive induction therapy consisting of idarubicin, cytarabine, etoposide, and all-trans retinoic acid with or without the addition of gemtuzumab ozogamicin.
Event-free survival in the gemtuzumab ozogamicin arm did not significantly differ from that in the standard arm (hazard ratio = 1.04, P = .10). However, the early death rate was improved with gemtuzumab ozogamicin (10.3%) compared with standard therapy (5.7%). Patients who had achieved complete remission or complete remission with incomplete hematologic recovery had a reduced cumulative incidence of relapse with gemtuzumab ozogamicin compared with standard therapy. There was no significant difference in the cumulative incidence of death between the arms. Of note, however, patients who were female, those who were up to 70 years old, and those who had FLT3 internal tandem duplication–negative disease experienced a significant benefit with gemtuzumab ozogamicin with respect to event-free survival and cumulative incidence of relapse.
In both arms, the causes of treatment-related deaths were mainly infections. The rates of adverse events did not differ between the two treatment groups.
Disclosure: For full disclosures of the study authors, visit ascopubs.org.