Leukemia & lymphoma · 2024
Azacitidine and venetoclax with or without pevonedistat in patients with newly diagnosed acute myeloid leukemia.
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Short Nicholas J, Wierzbowska Agnieszka, Cluzeau Thomas, Laribi Kamel, Recher Christian, Czyz Jaroslaw, Ochrem Bogdan, Ades Lionel, Gallego-Hernanz Maria Pilar, Heiblig Mael, Audisio Ernesta, Zarzycka Ewa, Li Shuli, Ferenc Nicholas, Yeh Tammie, Faller Douglas V, Sedarati Farhad, Papayannidis Cristina
Аннотация
UNLABELLED: This phase 2 study investigated pevonedistat + azacitidine + venetoclax (n = 83) versus azacitidine + venetoclax (n = 81) in patients with newly diagnosed acute myeloid leukemia (AML) ineligible for intensive chemotherapy. The study was stopped early following negative results from PANTHER, which evaluated pevonedistat in higher-risk myelodysplastic syndromes/chronic myelomonocytic leukemia or low-blast AML. Outcomes were analyzed up to the datacut. For pevonedistat + azacitidine + venetoclax versus azacitidine + venetoclax, the median follow-up was 8.44 versus 7.95 months; the complete remission (CR) rate was 45% versus 49%; composite CR (CCR; CR+CR with incomplete blood count recovery) was 77% versus 72%. There were no differences in event-free survival (primary endpoint; hazard ratio [HR]: 0.99; 95% confidence interval [CI]: 0.61-1.60; p = 0.477) or overall survival (HR: 1.42; 95% CI: 0.82-2.49; p = 0.896). In exploratory analyses in IDH-mutated AML, CCR rates were higher with pevonedistat + azacitidine + venetoclax versus azacitidine + venetoclax. Safety was similar between treatment arms. Efficacy/safety with azacitidine + venetoclax was consistent with the phase 3 VIALE-A study.
TRIAL REGISTRATION: NCT04266795.
TRIAL REGISTRATION: NCT04266795.