Randomized phase 2 study of otlertuzumab and bendamustine versus bendamustine in patients with relapsed chronic lymphocytic leukaemia

Tadeusz Robak, Andrzej Hellmann, Janusz Kloczko, Javier Loscertales, Ewa Lech-Maranda, John M. Pagel, Anthony Mato, John C. Byrd, Farrukh T. Awan, Holger Hebart, Jose A. Garcia-Marco, Brian T. Hill, Michael Hallek, Amy J. Eisenfeld, Scott C. Stromatt, Ulrich Jaeger

Research output: Contribution to journalArticlepeer-review

28 Scopus citations

Abstract

Otlertuzumab (TRU-016) is a humanized anti-CD37 protein therapeutic that triggers direct caspase-independent apoptosis of malignant B cells and induces antibody-dependent cell-mediated cytotoxicity. Patients with relapsed chronic lymphocytic leukaemia (CLL) received either otlertuzumab (20 mg/kg) weekly by IV infusion for two 28-day cycles then every 14 days for four 28-day cycles and IV bendamustine (70 mg/m2) on Days 1 and 2 of each cycle for up to six 28-day cycles or bendamustine alone. Thirty-two patients were treated with otlertuzumab and bendamustine and 33 with bendamustine alone. Overall response rate according to the International Workshop on Chronic Lymphocytic Leukaemia criteria was 69% in the otlertuzumab and bendamustine arm and 39% in the bendamustine alone arm (P = 0·025). Median progression-free survival (PFS) was 15·9 months in the otlertuzumab and bendamustine arm and 10·2 months in the bendamustine alone arm (P = 0·0192). There was a higher incidence of pyrexia (34% vs. 12%) and neutropenia (59% vs. 39%) with the combination but this did not result in a higher incidence of severe (grade 3/4) infections (13% vs. 27%). This combination significantly increased the response rate and prolonged the PFS over single agent bendamustine in patients with relapsed or refractory CLL.

Original languageEnglish (US)
Pages (from-to)618-628
Number of pages11
JournalBritish Journal of Haematology
Volume176
Issue number4
DOIs
StatePublished - Feb 1 2017
Externally publishedYes

Keywords

  • CLL
  • bendamustine
  • otlertuzumab

ASJC Scopus subject areas

  • Hematology

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