Randomized phase 2 study to assess the role of single-agent nivolumab to maintain remission in acute myeloid leukemia
Abstract: We conducted a multicenter, open-label, randomized phase 2 study to assess the efficacy of nivolumab (Nivo) as maintenance therapy for patients with acute myeloid leukemia (AML) in first complete remission (CR) or CR with incomplete hematologic recovery who were not candidates for stem cel...
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Elsevier
2025-05-01
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| Series: | Blood Advances |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S247395292500103X |
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| author | Athalia R. Pyzer Laura W. Dillon Elad Sharon Theodore G. Karrison Yuanyuan Zha Noreen Fulton Gege Gui Georgia Andrew Howard Streicher Kendra Sweet George Yaghmour Jane Jijun Liu Brian A. Jonas Aaron D. Schimmer Steven Grant Amer M. Zeidan Gerhard C. Hildebrandt Christopher H. Lowrey Ryan J. Mattison Neil Palmisiano Amandeep Salhotra Dimitrios Tzachanis Maria R. Baer Tara L. Lin Prapti Patel Helen Chen Walter M. Stadler Olatoyosi Odenike Richard A. Larson Thomas F. Gajewski Christopher S. Hourigan Wendy Stock Hongtao Liu |
| author_facet | Athalia R. Pyzer Laura W. Dillon Elad Sharon Theodore G. Karrison Yuanyuan Zha Noreen Fulton Gege Gui Georgia Andrew Howard Streicher Kendra Sweet George Yaghmour Jane Jijun Liu Brian A. Jonas Aaron D. Schimmer Steven Grant Amer M. Zeidan Gerhard C. Hildebrandt Christopher H. Lowrey Ryan J. Mattison Neil Palmisiano Amandeep Salhotra Dimitrios Tzachanis Maria R. Baer Tara L. Lin Prapti Patel Helen Chen Walter M. Stadler Olatoyosi Odenike Richard A. Larson Thomas F. Gajewski Christopher S. Hourigan Wendy Stock Hongtao Liu |
| author_sort | Athalia R. Pyzer |
| collection | DOAJ |
| description | Abstract: We conducted a multicenter, open-label, randomized phase 2 study to assess the efficacy of nivolumab (Nivo) as maintenance therapy for patients with acute myeloid leukemia (AML) in first complete remission (CR) or CR with incomplete hematologic recovery who were not candidates for stem cell transplant. Patients were stratified and randomized to observation (Obs) or Nivo (3 mg/kg IV every 2 weeks for 46 doses). The primary end point was progression-free survival (PFS) defined as time to disease relapse or death due to any reason. Secondary end points included overall survival (OS), and evaluation of adverse events (AEs) after Nivo administration. Eighty patients were enrolled with median duration of follow-up of 24 months (33 months among survivors). PFS was 13.2 months in the Nivo arm and 10.9 months in the Obs arm. Overall PFS curves were not statistically significantly different. The median OS was 53.9 months in the Nivo arm and 30.9 months in the Obs arm. There were more AEs of any type (regardless of attribution) on the Nivo arm; 27 patients (71%) on the Nivo arm had a grade ≥3 AE compared with 5 patients (12%) on the Obs arm (P < .001). Nivo maintenance after AML chemotherapy failed to improve the PFS and OS in this randomized phase 2 study. There were increased AEs and serious AEs (SAEs) with Nivo, but these AEs and SAEs were expected and manageable. This trial was registered at www.ClinicalTrials.gov as #NCT02275533. |
| format | Article |
| id | doaj-art-515b2a72c8ad48e7895e1d058ddc4711 |
| institution | OA Journals |
| issn | 2473-9529 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Blood Advances |
| spelling | doaj-art-515b2a72c8ad48e7895e1d058ddc47112025-08-20T02:28:26ZengElsevierBlood Advances2473-95292025-05-01992144215210.1182/bloodadvances.2024015176Randomized phase 2 study to assess the role of single-agent nivolumab to maintain remission in acute myeloid leukemiaAthalia R. Pyzer0Laura W. Dillon1Elad Sharon2Theodore G. Karrison3Yuanyuan Zha4Noreen Fulton5Gege Gui6Georgia Andrew7Howard Streicher8Kendra Sweet9George Yaghmour10Jane Jijun Liu11Brian A. Jonas12Aaron D. Schimmer13Steven Grant14Amer M. Zeidan15Gerhard C. Hildebrandt16Christopher H. Lowrey17Ryan J. Mattison18Neil Palmisiano19Amandeep Salhotra20Dimitrios Tzachanis21Maria R. Baer22Tara L. Lin23Prapti Patel24Helen Chen25Walter M. Stadler26Olatoyosi Odenike27Richard A. Larson28Thomas F. Gajewski29Christopher S. Hourigan30Wendy Stock31Hongtao Liu32Department of Medicine, The University of Chicago, Chicago, ILLaboratory of Myeloid Malignancies, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MDDivision of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MDDepartment of Public Health Sciences, The University of Chicago, Chicago, ILDepartment of Medicine, The University of Chicago, Chicago, ILDepartment of Medicine, The University of Chicago, Chicago, ILLaboratory of Myeloid Malignancies, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD; Department of Biostatistics, Fralin Biomedical Research Institute, Virginia Tech Fralin Biomedical Research Institute Cancer Research Center, Washington, DCLaboratory of Myeloid Malignancies, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MDDivision of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MDDepartment of Malignant Hematology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FLJane Anne Nohl Division of Hematology and Center for the Study of Blood Diseases, University of Southern California Norris Comprehensive Cancer Center of Keck School of Medicine, University of Southern California, Los Angeles, CAIllinois Cancer Care and Heartland National Community of Oncology Research Programs, Peoria ILDivision of Malignant Hematology/Cellular Therapy and Transplantation, Department of Internal Medicine, University of California Davis School of Medicine, Sacramento, CADepartment of Medical Biophysics, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, CanadaDivision of Hematology/Oncology and Palliative Care Virginia Commonwealth University Health Sciences Center, Richmond, VASection of Hematology, Department of Internal Medicine, Yale University School of Medicine, New Haven, CTDivision of Hematology and Medical Oncology, Ellis Fischel Cancer Center, University of Missouri, Columbia, MODivision of Hematology, Dartmouth-Hitchcock Medical Center and Norris Cotton Cancer Center, Lebanon, NHDepartment of Medicine, Carbone Cancer Center, University of Wisconsin, Madison, WIProgram for Hematologic Malignancies, Rutgers Cancer Institute of New Jersey, Rutgers University, New Brunswick, NJDepartment of Hematology & Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CADepartment of Medicine, Moores Cancer Center, University of California San Diego, San Diego, CADepartment of Medicine, Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore, MDDivision of Hematologic Malignancies and Cellular Therapeutics, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KSServier Pharmaceuticals, LLC, Boston, MADivision of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MDDepartment of Medicine, The University of Chicago, Chicago, ILDepartment of Medicine, The University of Chicago, Chicago, ILDepartment of Medicine, The University of Chicago, Chicago, ILDepartment of Pathology, The University of Chicago, Chicago, ILLaboratory of Myeloid Malignancies, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD; Department of Biostatistics, Fralin Biomedical Research Institute, Virginia Tech Fralin Biomedical Research Institute Cancer Research Center, Washington, DCDepartment of Medicine, The University of Chicago, Chicago, ILDepartment of Medicine, The University of Chicago, Chicago, IL; Division of Hematology, Medical Oncology and Palliative Care, Department of Medicine, University of Wisconsin-Madison, Madison, WI; Correspondence: Hongtao Liu, University of Wisconsin-Madison, Medicine, Wisconsin Institutes for Medical Research, 1111 Highland Ave, Madison, WI 53705-2275;Abstract: We conducted a multicenter, open-label, randomized phase 2 study to assess the efficacy of nivolumab (Nivo) as maintenance therapy for patients with acute myeloid leukemia (AML) in first complete remission (CR) or CR with incomplete hematologic recovery who were not candidates for stem cell transplant. Patients were stratified and randomized to observation (Obs) or Nivo (3 mg/kg IV every 2 weeks for 46 doses). The primary end point was progression-free survival (PFS) defined as time to disease relapse or death due to any reason. Secondary end points included overall survival (OS), and evaluation of adverse events (AEs) after Nivo administration. Eighty patients were enrolled with median duration of follow-up of 24 months (33 months among survivors). PFS was 13.2 months in the Nivo arm and 10.9 months in the Obs arm. Overall PFS curves were not statistically significantly different. The median OS was 53.9 months in the Nivo arm and 30.9 months in the Obs arm. There were more AEs of any type (regardless of attribution) on the Nivo arm; 27 patients (71%) on the Nivo arm had a grade ≥3 AE compared with 5 patients (12%) on the Obs arm (P < .001). Nivo maintenance after AML chemotherapy failed to improve the PFS and OS in this randomized phase 2 study. There were increased AEs and serious AEs (SAEs) with Nivo, but these AEs and SAEs were expected and manageable. This trial was registered at www.ClinicalTrials.gov as #NCT02275533.http://www.sciencedirect.com/science/article/pii/S247395292500103X |
| spellingShingle | Athalia R. Pyzer Laura W. Dillon Elad Sharon Theodore G. Karrison Yuanyuan Zha Noreen Fulton Gege Gui Georgia Andrew Howard Streicher Kendra Sweet George Yaghmour Jane Jijun Liu Brian A. Jonas Aaron D. Schimmer Steven Grant Amer M. Zeidan Gerhard C. Hildebrandt Christopher H. Lowrey Ryan J. Mattison Neil Palmisiano Amandeep Salhotra Dimitrios Tzachanis Maria R. Baer Tara L. Lin Prapti Patel Helen Chen Walter M. Stadler Olatoyosi Odenike Richard A. Larson Thomas F. Gajewski Christopher S. Hourigan Wendy Stock Hongtao Liu Randomized phase 2 study to assess the role of single-agent nivolumab to maintain remission in acute myeloid leukemia Blood Advances |
| title | Randomized phase 2 study to assess the role of single-agent nivolumab to maintain remission in acute myeloid leukemia |
| title_full | Randomized phase 2 study to assess the role of single-agent nivolumab to maintain remission in acute myeloid leukemia |
| title_fullStr | Randomized phase 2 study to assess the role of single-agent nivolumab to maintain remission in acute myeloid leukemia |
| title_full_unstemmed | Randomized phase 2 study to assess the role of single-agent nivolumab to maintain remission in acute myeloid leukemia |
| title_short | Randomized phase 2 study to assess the role of single-agent nivolumab to maintain remission in acute myeloid leukemia |
| title_sort | randomized phase 2 study to assess the role of single agent nivolumab to maintain remission in acute myeloid leukemia |
| url | http://www.sciencedirect.com/science/article/pii/S247395292500103X |
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