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Rebecca Olin, MD, MS


Nivolumab Plus Front-Line Chemotherapy in Newly Diagnosed AML

By: Cordi Craig
Posted: Sunday, March 1, 2020

The addition of the PD-1 inhibitor nivolumab to front-line therapy with idarubicin and cytarabine may improve responses in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome, according to a study published in The Lancet Haematology. Farhad Ravandi, MD, Professor of Medicine at The University of Texas MD Anderson Cancer Center, and colleagues proposed that the combination may induce sustained responses and reduce the risk of relapse.

This single-arm, phase II trial included 44 newly diagnosed patients with AML or high-risk myelodysplastic syndrome, half of whom had adverse genetic risk by European Leukemia Network classification. The patients received nivolumab in addition to front-line therapy with idarubicin and cytarabine.

The median event-free survival was not reached after a median follow-up of 17.25 months. The median relapse-free survival among patients who responded and overall survival was 18.5 months. Overall, six patients had grade 3 and 4 immune-related adverse events including two cases of rash, two cases of colitis, and one case each of transaminitis, pancreatitis, and cholecystitis. Among the overall patient population, 19 patients (43%) achieved a response and proceeded to allogeneic stem cell transplantation. Of those who responded, five patients (26%) had grade 3 and 4 graft-versus-host disease. Nivolumab did not cause any treatment-related deaths.

“Post-transplant severe graft-versus-host disease could be improved, and earlier initiation of checkpoint inhibitor therapy is warranted in future studies,” the authors concluded.

Disclosure: For full disclosures of study authors, visit

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