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@ARTICLE{Loges:300110,
      author       = {S. Loges$^*$ and M. Heuser and J. Chromik and G.
                      Sutamtewagul and S. Kapp-Schwoerer and M. Crugnola and N. Di
                      Renzo and R. Lemoli and D. Mattei and W. Fiedler and Y.
                      Alvarado-Valero and I. Ben-Batalla$^*$ and J.
                      Waizenegger$^*$ and L.-M. Rieckmann$^*$ and M. Janning$^*$
                      and M. Collienne$^*$ and C. D. Imbusch$^*$ and N. Beumer$^*$
                      and D. Micklem and L. H Nilsson and N. Madeleine and N.
                      McCracken and C. Oliva and C. Gorcea-Carson and B. T.
                      Gjertsen},
      title        = {{B}emcentinib as monotherapy and in combination with
                      low-dose cytarabine in acute myeloid leukemia patients unfit
                      for intensive chemotherapy: a phase 1b/2a trial.},
      journal      = {Nature Communications},
      volume       = {16},
      number       = {1},
      issn         = {2041-1723},
      address      = {[London]},
      publisher    = {Springer Nature},
      reportid     = {DKFZ-2025-00608},
      pages        = {2846},
      year         = {2025},
      note         = {#EA:A420#},
      abstract     = {Beyond first line, the prognosis of relapsed/refractory
                      (R/R) acute myeloid leukemia (AML) patients is poor with
                      limited treatment options. Bemcentinib is an orally
                      bioavailable, potent, highly selective inhibitor of AXL, a
                      receptor tyrosine kinase associated with poor prognosis,
                      chemotherapy resistance and decreased antitumor immune
                      response. We report bemcentinib monotherapy and
                      bemcentinib+low-dose cytarabine combination therapy arms
                      from the completed BerGenBio-funded open-label Phase 1/2b
                      trial NCT02488408 ( www.clinicaltrials.gov ), in patients
                      unsuitable for intensive chemotherapy. The primary objective
                      in the monotherapy arm was identification of maximum
                      tolerated dose with secondary objectives to identify
                      dose-limiting toxicities, safety and efficacy, and
                      bemcentinib pharmacokinetic profile. In the combination arm,
                      the primary objective was safety and tolerability, with
                      efficacy and pharmacokinetics as secondary objectives.
                      Safety and tolerability were based on standard clinical
                      laboratory safety tests and Common Terminology Criteria for
                      Adverse Events version 4. Bemcentinib monotherapy (32 R/R, 2
                      treatment-naïve AML and 2 myelodysplasia patients) was
                      well-tolerated and a loading/maintenance dose of 400/200 mg
                      was selected for combination treatment, comprising 30 R/R
                      and 6 treatment-naïve AML patients. The most common grade
                      3/4 treatment-related adverse events were cytopenia, febrile
                      neutropenia and asymptomatic QTcF prolongation, with no
                      grade 5 events reported. In conclusion, bemcentinib+low-dose
                      cytarabine was safe and well tolerated.},
      keywords     = {Humans / Cytarabine: administration $\&$ dosage /
                      Cytarabine: adverse effects / Cytarabine: therapeutic use /
                      Cytarabine: pharmacokinetics / Leukemia, Myeloid, Acute:
                      drug therapy / Male / Middle Aged / Female / Aged /
                      Antineoplastic Combined Chemotherapy Protocols: adverse
                      effects / Antineoplastic Combined Chemotherapy Protocols:
                      therapeutic use / Antineoplastic Combined Chemotherapy
                      Protocols: pharmacokinetics / Antineoplastic Combined
                      Chemotherapy Protocols: administration $\&$ dosage / Adult /
                      Axl Receptor Tyrosine Kinase / Maximum Tolerated Dose /
                      Receptor Protein-Tyrosine Kinases: antagonists $\&$
                      inhibitors / Proto-Oncogene Proteins: antagonists $\&$
                      inhibitors / Cytarabine (NLM Chemicals) / Axl Receptor
                      Tyrosine Kinase (NLM Chemicals) / AXL protein, human (NLM
                      Chemicals) / Receptor Protein-Tyrosine Kinases (NLM
                      Chemicals) / Proto-Oncogene Proteins (NLM Chemicals)},
      cin          = {A420 / B330},
      ddc          = {500},
      cid          = {I:(DE-He78)A420-20160331 / I:(DE-He78)B330-20160331},
      pnm          = {311 - Zellbiologie und Tumorbiologie (POF4-311)},
      pid          = {G:(DE-HGF)POF4-311},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:40122885},
      doi          = {10.1038/s41467-025-58179-6},
      url          = {https://inrepo02.dkfz.de/record/300110},
}