Otlertuzumab (TRU-016), an anti-CD37 monospecific ADAPTIR therapeutic protein, for relapsed or refractory NHL patients

John M. Pagel, Stephen E. Spurgeon, John C. Byrd, Farrukh T. Awan, Ian W. Flinn, Mark C. Lanasa, Amy J. Eisenfeld, Scott C. Stromatt, Ajay K. Gopal

Research output: Contribution to journalArticle

23 Scopus citations

Abstract

CD37 is cell surface tetraspanin present on normal and malignant B cells. Otlertuzumab (TRU-016) is a novel humanized anti-CD37 protein therapeutic. Patients with relapsed or refractory follicular non-Hodgkin lymphoma (FL), mantle cell lymphoma (MCL), or Waldenström's macroglobulinaemia (WM) received otlertuzumab at 20 mg/kg administered intravenously once a week for up to 8 weeks followed by 4 monthly doses. Sixteen patients were treated; median age was 62·5 years (range, 41-81), and median number of prior regimens was 4 (range, 1-7). Twelve patients were refractory to prior treatment, 5 were refractory to rituximab. The mean terminal half-life was 9·5 days. Lymph node reduction of ≥50% by computerized tomography scan measurements was seen in 3 of 12 patients, including one FL patient who had a partial response. One WM patient had a minor response. The most frequent adverse events were neutropenia, fatigue, nausea, thrombocytopenia, diarrhoea, and peripheral oedema; most were grade 1/2. Otlertuzumab treatment appears to have been well tolerated by the patients in this study. Clinical activity was observed in this small heterogeneous cohort of highly refractory, heavily pretreated B-cell non-Hodgkin lymphoma patients. These data suggest that further clinical investigation in non-Hodgkin lymphoma is warranted.

Original languageEnglish (US)
Pages (from-to)38-45
Number of pages8
JournalBritish Journal of Haematology
Volume168
Issue number1
DOIs
StatePublished - Jan 1 2015

Keywords

  • AntiCD37
  • Clinical trial
  • Non-Hodgkin lymphoma
  • Otlertuzumab

ASJC Scopus subject areas

  • Hematology

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    Pagel, J. M., Spurgeon, S. E., Byrd, J. C., Awan, F. T., Flinn, I. W., Lanasa, M. C., Eisenfeld, A. J., Stromatt, S. C., & Gopal, A. K. (2015). Otlertuzumab (TRU-016), an anti-CD37 monospecific ADAPTIR therapeutic protein, for relapsed or refractory NHL patients. British Journal of Haematology, 168(1), 38-45. https://doi.org/10.1111/bjh.13099