For acute myeloid leukemia remission, nivolumab maintenance therapy shows no benefit.
In a randomized phase 2 study of 79 patients with acute myeloid leukemia in first complete remission, nivolumab maintenance therapy did not improve progression-free survival or overall survival compared with observation.
Adverse events were more frequent in the nivolumab arm, with 71% experiencing grade ≥ 3 events vs 12% in the observation arm.A multicenter, open-label, randomized phase 2 trial enrolled 79 patients with AML in first complete remission or complete remission with incomplete hematologic recovery who were not candidates for stem cell transplant. Participants were randomized to either observation or nivolumab arm , with a median follow-up duration of 24 months. Primary endpoint was progression-free survival, defined as time to disease relapse or death, while secondary endpoints included overall survival and evaluation of adverse events. Analysis included measurement of measurable residual disease through ultrasensitive duplex DNA sequencing in 55 patients and targeted RNA sequencing in two patients before randomization.Median progression-free survival duration was 13.2 months in the nivolumab arm vs 10.9 months in the observation arm in the nivolumab arm vs 30.9 months in the observation arm than MRD negative patients.“With negative results using checkpoint inhibitors alone , now in both the MRD setting and in the front line, the utility of targeting the PD1-PDL1 pathway in unselected AML appears limited…. It remains possible that further correlatives studies might identify a subset of patients with AML who may responses to immune checkpoint inhibition,” wrote the authors of the study.The study was led by Athalia Pyzer and Hongtao Liu, The University of Chicago in Chicago. It wasAccording to the authors, subgroup analysis in the cohort of MRD positive patients did not demonstrate any effect of nivolumab on clinical outcomes, but these comparisons were underpowered. The researchers noted that other immune escape mechanisms, even beyond checkpoint pathways, likely contribute to the persistence of this disease.The study was supported by the Intramural Research Program of the National Heart, Lung, and Blood Institute, a University of Chicago Comprehensive Cancer Center pilot grant, the Ullman Scholar Award, and the Elsa U. Pardee Foundation. Additional disclosures are noted in the original article. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Acute Myeloid Leukemia Acute Myelocytic Leukemia Acute Myelogenous Leukemia Aml Acute Granulocytic Leukemia Acute Nonlymphocytic Leukemia Acute Myeloblastic Leukaemia Acute Myeloid Leukaemia Acute Myelocytic Leukemia Acute Myelogenous Leukaemia Acute Granulocytic Leukaemia Acute Nonlymphocytic Leukaemia Remission Leukemia Leukaemia Blood Cancer Blood
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