Leukemia & lymphoma · 2022
A multi-arm phase Ib/II study designed for rapid, parallel evaluation of novel immunotherapy combinations in relapsed/refractory acute myeloid leukemia.
Клиническое исследование I фазыКлиническое исследование II фазыСтатьяПоддержка исследования: вне правительства СШАПоддержка NIH: внешняя программаНазвание и аннотация: Перевод в очереди
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Short Nicholas J, Borthakur Gautam, Pemmaraju Naveen, Dinardo Courtney D, Kadia Tapan M, Jabbour Elias, Konopleva Marina, Macaron Walid, Ning Jing, Ma Junsheng, Pierce Sherry, Alvarado Yesid, Sasaki Koji, Takahashi Koichi, Estrov Zeev, Masarova Lucia, Issa Ghayas C, Montalban-Bravo Guillermo, Andreeff Michael, Burger Jan A, Miller Darla, Alexander Lynette, Naing Aung, Garcia-Manero Guillermo, Ravandi Farhad, Daver Naval
Аннотация
We conducted a phase Ib/II multi-arm, parallel cohort study to simultaneously evaluate various immunotherapeutic agents and combinations in relapsed/refractory acute myeloid leukemia (AML). Overall, 50 patients were enrolled into one of 6 arms: (A) single agent PF-04518600 (OX40 agonist monoclonal antibody), (B) azacitidine + venetoclax + gemtuzumab ozogamicin (GO), (C) azacitidine + avelumab (anti-PD-L1 monoclonal antibody) + GO, (D) azacitidine + venetoclax + avelumab, (E) azacitidine + avelumab + PF-04518600, and (F) glasdegib + GO. Among all regimens evaluated, azacitidine + venetoclax + GO appeared most promising. In this arm, the CR/CRi rates among venetoclax-naïve and prior venetoclax-exposed patients were 50% and 22%, respectively, and the 1-year OS rate was 31%. This study shows the feasibility of a conducting a multi-arm trial to efficiently and simultaneously evaluate novel therapies in AML, a needed strategy in light of the plethora of emerging therapies. This trial was registered at www.clinicaltrials.gov as NCT03390296.