A phase 1/2 trial of ublituximab, a novel anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia previously exposed to rituximab

Ahmed Sawas, Charles M. Farber, Marshall T. Schreeder, Mazen Y. Khalil, Daruka Mahadevan, Changchun Deng, Jennifer E. Amengual, Petros G. Nikolinakos, Jill M. Kolesar, John G. Kuhn, Peter Sportelli, Hari P. Miskin, Owen A. O'Connor

Research output: Contribution to journalArticle

26 Scopus citations

Abstract

This phase 1/2 study evaluated the safety, pharmacokinetic behavior and anti-tumour activity of ublituximab, a unique type I, chimeric, glycoengineered anti-CD20 monoclonal antibody, in rituximab-relapsed or -refractory patients with B-cell non-Hodgkin lymphoma (B-NHL) or chronic lymphocytic leukaemia (CLL). Induction therapy (doses of 450–1200 mg) consisted of 4 weekly infusions in cycle 1 for NHL and 3 weekly infusions in cycles 1 and 2 for CLL. Patients received ublituximab maintenance monthly during cycles 3–5, then once every 3 months for up to 2 years. Enrolled patients with B-NHL (n = 27) and CLL (n = 8) had a median of 3 prior therapies. No dose-limiting toxicities or unexpected adverse events (AEs) occurred. The most common AEs were infusion-related reactions (40%; grade 3/4, 0%); fatigue (37%; grade 3/4, 3%); pyrexia (29%; grade 3/4, 0%); and diarrhoea (26%; grade 3/4, 0%). Common haematological AEs were neutropenia (14%; grade 3/4, 14%) and anaemia (11%; grade 3/4, 6%). The overall response rate for evaluable patients (n = 31) was 45% (13% complete responses, 32% partial responses). Median duration of response and progression-free survival were 9·2 months and 7·7 months, respectively. Ublituximab was well-tolerated and efficacious in a heterogeneous and highly rituximab-pre-treated patient population.

Original languageEnglish (US)
Pages (from-to)243-253
Number of pages11
JournalBritish Journal of Haematology
Volume177
Issue number2
DOIs
StatePublished - Apr 1 2017
Externally publishedYes

Keywords

  • B-cell lymphoma
  • LFB-R603
  • TG-1101
  • anti-CD20 monoclonal antibody
  • ublituximab

ASJC Scopus subject areas

  • Hematology

Fingerprint Dive into the research topics of 'A phase 1/2 trial of ublituximab, a novel anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia previously exposed to rituximab'. Together they form a unique fingerprint.

Cite this