Treatment of steroid resistant acute graft versus host disease with an anti-CD26 monoclonal antibody—Begelomab

Andrea Bacigalupo, Emanuele Angelucci, Anna Maria Raiola, Riccardo Varaldo, Carmen Di Grazia, Francesca Gualandi, Edoardo Benedetti, Antonio Risitano, Maurizio Musso, Francesco Zallio, Fabio Ciceri, Patrizia Chiusolo, Simona Sica, Alessandro Rambaldi, Francesca Bonifazi, Matteo Parma, Massimo Martino, Francesco Onida, Anna Paola Iori, Carmine SelleriCarlo Borghero, Alice Bertaina, Lucia Prezioso, Mattia Algeri, Franco Locatelli

Research output: Contribution to journalArticle

Abstract

We have treated 69 patients with steroid refractory acute graft versus host disease (SR-aGvHD), with an anti-CD26 monoclonal antibody (Begelomab): 28 patients in two prospective studies (EudraCT No. 2007-005809-21; EudraCT No. 2012-001353-19), and 41 patients on a compassionate use study. The median age of patients was 42 and 44 years; the severity of GvHD was as follows: grade II in 8 patients, grade III in 33, and grade IV in 28 patients. There were no adverse events directly attributable to the antibody. Day 28 response was 75% in the prospective studies and 61% in the compassionate use patients, with complete response rates of 11 and 12%. Response for grade III GvHD was 83 and 73% in the two groups; response in grade IV GvHD was 66 and 56% in the two groups. Non relapse mortality (NRM) at 6 months was 28 and 38%. Overall there were 64, 56, 68% responses for skin, liver, and gut stage 3–4 GvHD. The overall survival at 1 year was 50% for the prospective studies and 33% for the compassionate use patients. In conclusion, Begelomab induces over 60% responses in SR-aGvHD, including patients with severe gut and liver GvHD, having failed one or more lines of treatment.

Original languageEnglish
JournalBone Marrow Transplantation
DOIs
Publication statusAccepted/In press - Jan 1 2020

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ASJC Scopus subject areas

  • Hematology
  • Transplantation

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