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Cited by 555

The DOI matches its Crossref record; 33 of the 33 references it cites were found in a registry or an index.

Efficacy, Safety, and Biomarkers of Response to Azacitidine and Nivolumab in Relapsed/Refractory Acute Myeloid Leukemia: A Nonrandomized, Open-Label, Phase II Study

Open access
Daver, Naval, Garcia-Manero, Guillermo, Basu, Sreyashi, Boddu, Prajwal C., Alfayez, Mansour, Cortes, Jorge E., Konopleva, Marina, Ravandi-Kashani, Farhad, Jabbour, Elias, Kadia, Tapan, Nogueras-Gonzalez, Graciela M., Ning, Jing, Pemmaraju, Naveen, DiNardo, Courtney D., Andreeff, Michael, Pierce, Sherry A., Gordon, Tauna, Kornblau, Steven M., Flores, Wilmer, Alhamal, Zainab, Bueso-Ramos, Carlos, Jorgensen, Jeffrey L., Patel, Keyur P., Blando, Jorge, Allison, James P., Sharma, Padmanee, Kantarjian, Hagop·2019·Cancer Discovery
DOI 10.1158/2159-8290.cd-18-0774
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Abstract

Preclinical models have shown that blocking PD-1/PD-L1 pathways enhances antileukemic responses. Azacitidine upregulates PD-1 and IFNγ signaling. We therefore conducted this single-arm trial, in which patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) were treated with azacitidine 75 mg/m2 days 1 to 7 intravenously or subcutaneously with nivolumab 3 mg/kg intravenously on days 1 and 14, every 4 to 6 weeks. For the seventy patients who were treated, the median age was 70 years (range, 22–90) and the median number of prior therapies received was 2 (range, 1–7). The overall response rate (ORR) was 33%, including 15 (22%) complete remission/complete remission with insufficient recovery of counts, 1 partial response, and 7 patients with hematologic improvement maintained >6 months. Six patients (9%) had stable disease >6 months. The ORR was 58% and 22%, in hypomethylating agent (HMA)–naïve (n = 25) and HMA-pretreated (n = 45) patients, respectively. Grade 3 to 4 immune-related adverse events occurred in 8 (11%) patients. Pretherapy bone marrow and peripheral blood CD3 and CD8 were significantly predictive for response on flow cytometry. CTLA4 was significantly upregulated on CD4+ Teff in nonresponders after 2 and 4 doses of nivolumab. Azacitidine and nivolumab therapy produced an encouraging response rate and overall survival in patients with R/R AML, particularly in HMA-naïve and salvage 1 patients. Pretherapy bone marrow aspirate and peripheral blood CD3 percentage may be biomarkers for patient selection. Significance: Azacitidine in combination with nivolumab appeared to be a safe and effective therapy in patients with AML who were salvage 1, prior hypomethylator-naïve, or had increased pretherapy CD3+ bone marrow infiltrate by flow cytometry or IHC. Bone marrow CD3 and CD8 are relatively simple assays that should be incorporated to select patients in future trials. This article is highlighted in the In This Issue feature, p. 305

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Metadata

Authors
Daver, N., Garcia-Manero, G., Basu, S., Boddu, P. C., Alfayez, M., Cortes, J. E., Konopleva, M., Ravandi-Kashani, F., Jabbour, E., Kadia, T., Nogueras-Gonzalez, G. M., Ning, J., Pemmaraju, N., DiNardo, C. D., Andreeff, M., Pierce, S. A., Gordon, T., Kornblau, S. M., Flores, W., Alhamal, Z., Bueso-Ramos, C., Jorgensen, J. L., Patel, K. P., Blando, J., Allison, J. P., Sharma, P., & Kantarjian, H.
Venue
Cancer Discovery
Publisher
American Association for Cancer Research (AACR)
Published
2019-03-01
Volume
9
Issue
3
Pages
370-383
ISSN
  • 2159-8274 (ISSN-L)
  • 2159-8290
DOI
10.1158/2159-8290.cd-18-0774
OpenAlex
W2900410545
Cited by
555
References
33
FWCI
32.07
Type
journal article
Language
en
Open access
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CoChat. (2026). Citation check: Efficacy, Safety, and Biomarkers of Response to Azacitidine and Nivolumab in Relapsed/Refractory Acute Myeloid Leukemia: A Nonrandomized, Open-Label, Phase II Study. https://app.cochat.ai/papers/10.1158/2159-8290.cd-18-0774
The paper
Daver, N., Garcia-Manero, G., Basu, S., Boddu, P. C., Alfayez, M., Cortes, J. E., Konopleva, M., Ravandi-Kashani, F., Jabbour, E., Kadia, T., Nogueras-Gonzalez, G. M., Ning, J., Pemmaraju, N., DiNardo, C. D., Andreeff, M., Pierce, S. A., Gordon, T., Kornblau, S. M., Flores, W., . . . Kantarjian, H. (2019). Efficacy, Safety, and Biomarkers of Response to Azacitidine and Nivolumab in Relapsed/Refractory Acute Myeloid Leukemia: A Nonrandomized, Open-Label, Phase II Study. Cancer Discovery. https://doi.org/10.1158/2159-8290.cd-18-0774

Data sources

Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.