Pevonedistat, a first-in-class NEDD8-activating enzyme inhibitor, combined with azacitidine in patients with AML by Ronan T. Swords, Steven Coutre, Michael.

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Pevonedistat, a first-in-class NEDD8-activating enzyme inhibitor, combined with azacitidine in patients with AML by Ronan T. Swords, Steven Coutre, Michael B. Maris, Joshua F. Zeidner, James M. Foran, Jose Cruz, Harry P. Erba, Jesus G. Berdeja, Wayne Tam, Saran Vardhanabhuti, Iwona Pawlikowska-Dobler, Hélène M. Faessel, Ajeeta B. Dash, Farhad Sedarati, Bruce J. Dezube, Douglas V. Faller, and Michael R. Savona Blood Volume 131(13):1415-1424 March 29, 2018 ©2018 by American Society of Hematology

Mean (standard deviation) PK profile after 1-hour IV infusion of PEV in combination with AZA in elderly patients with treatment-naive AML. *Derived from single-agent PEV data in patients with AML.9. Mean (standard deviation) PK profile after 1-hour IV infusion of PEV in combination with AZA in elderly patients with treatment-naive AML. *Derived from single-agent PEV data in patients with AML.9 Ronan T. Swords et al. Blood 2018;131:1415-1424 ©2018 by American Society of Hematology

Duration of response. Duration of response. Bar length reflects duration of response. End of duration is due to progressive disease (PD), last disease assessment, or last follow-up. Gray triangles indicate the 10 patients who did not have postbaseline disease assessment and are listed as not evaluable (NE) but included as “nonresponders” in the ITT analysis. SD, stable disease. Ronan T. Swords et al. Blood 2018;131:1415-1424 ©2018 by American Society of Hematology

Kaplan-Meier survival analyses in the MTD cohort. Kaplan-Meier survival analyses in the MTD cohort. (A) OS of patients treated at the MTD, including the 9 response-unevaluable patients. (B) OS of de novo AML vs secondary AML patients. Ronan T. Swords et al. Blood 2018;131:1415-1424 ©2018 by American Society of Hematology

Heatmap showing mutational status of 12 frequently mutated genes and response data for patients in the MTD cohort. Heatmap showing mutational status of 12 frequently mutated genes and response data for patients in the MTD cohort. Genetic mutation data for 33 of 61 patients identified using a targeted NGS panel are shown. Each column represents a single patient, and each row represents a single gene. Presence of a mutation in any gene is denoted in red. Mutation frequency = (number of patients with mutation/number of NGS-evaluable patients) × 100. In this figure, responders = CR + CRi + PR. Ronan T. Swords et al. Blood 2018;131:1415-1424 ©2018 by American Society of Hematology