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@ARTICLE{Apostolova:277924,
      author       = {P. Apostolova$^*$ and S. Kreutmair$^*$ and C. Toffalori and
                      M. Punta and S. Unger and A.-C. Burk$^*$ and C. Wehr and K.
                      Maas-Bauer and W. Melchinger and E. Haring$^*$ and R.
                      Hoefflin and K. Shoumariyeh$^*$ and V. Hupfer and E. M.
                      Lauer and S. Duquesne and T. Lowinus and N. Gonzalo Núñez
                      and C. Alberti and S. da Costa Pereira and C. H. Merten and
                      L. Power and M. Weiss and C. Böke and D. Pfeifer and R.
                      Marks and H. Bertz and R. Wäsch and G. Ihorst and B.
                      Gentner and J. Duyster and M. Börries$^*$ and G. Andrieux
                      and J. Finke and B. Becher and L. Vago and R. Zeiser$^*$},
      title        = {{P}hase {II} trial of hypomethylating agent combined with
                      nivolumab for acute myeloid leukaemia relapse after
                      allogeneic haematopoietic cell transplantation-{I}mmune
                      signature correlates with response.},
      journal      = {British journal of haematology},
      volume       = {203},
      number       = {2},
      issn         = {0007-1048},
      address      = {Oxford [u.a.]},
      publisher    = {Wiley-Blackwell},
      reportid     = {DKFZ-2023-01580},
      pages        = {264-281},
      year         = {2023},
      note         = {2023 Oct;203(2):264-281},
      abstract     = {Acute myeloid leukaemia (AML) relapse after allogeneic
                      haematopoietic cell transplantation (allo-HCT) is often
                      driven by immune-related mechanisms and associated with poor
                      prognosis. Immune checkpoint inhibitors combined with
                      hypomethylating agents (HMA) may restore or enhance the
                      graft-versus-leukaemia effect. Still, data about using this
                      combination regimen after allo-HCT are limited. We conducted
                      a prospective, phase II, open-label, single-arm study in
                      which we treated patients with haematological AML relapse
                      after allo-HCT with HMA plus the anti-PD-1 antibody
                      nivolumab. The response was correlated with DNA-, RNA- and
                      protein-based single-cell technology assessments to identify
                      biomarkers associated with therapeutic efficacy. Sixteen
                      patients received a median number of 2 (range 1-7) nivolumab
                      applications. The overall response rate (CR/PR) at day 42
                      was $25\%,$ and another $25\%$ of the patients achieved
                      stable disease. The median overall survival was 15.6 months.
                      High-parametric cytometry documented a higher frequency of
                      activated (ICOS+ , HLA-DR+ ), low senescence (KLRG1- , CD57-
                      ) CD8+ effector T cells in responders. We confirmed these
                      findings in a preclinical model. Single-cell transcriptomics
                      revealed a pro-inflammatory rewiring of the expression
                      profile of T and myeloid cells in responders. In summary,
                      the study indicates that the post-allo-HCT HMA/nivolumab
                      combination induces anti-AML immune responses in selected
                      patients and could be considered as a bridging approach to a
                      second allo-HCT. Trial-registration: EudraCT-No.
                      2017-002194-18.},
      keywords     = {acute myeloid leukaemia (Other) / allogeneic haematopoietic
                      cell transplantation (Other) / hypomethylating agent (Other)
                      / immune checkpoint inhibition (Other) / immune phenotype
                      (Other) / relapse (Other) / single-cell RNA-sequencing
                      (Other) / single-cell immunomonitoring (Other)},
      cin          = {FR01},
      ddc          = {610},
      cid          = {I:(DE-He78)FR01-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:37539479},
      doi          = {10.1111/bjh.19007},
      url          = {https://inrepo02.dkfz.de/record/277924},
}