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Ublituximab ( TG ‐1101), a novel glycoengineered anti‐ CD 20 antibody, in combination with ibrutinib is safe and highly active in patients with relapsed and/or refractory chronic lymphocytic leukaemia: results of a phase 2 trial
Author(s) -
Sharman Jeff P.,
Farber Charles M.,
Mahadevan Daruka,
Schreeder Marshall T.,
Brooks Heather D.,
Kolibaba Kathryn S.,
Fanning Suzanne,
Klein Leonard,
Greenwald Daniel R.,
Sportelli Peter,
Miskin Hari P.,
Weiss Michael S.,
Burke John M.
Publication year - 2017
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.14447
Subject(s) - ibrutinib , medicine , adverse effect , refractory (planetary science) , oncology , phases of clinical research , chronic lymphocytic leukemia , clinical trial , leukemia , physics , astrobiology
Summary Ibrutinib is effective in patients with chronic lymphocytic leukaemia ( CLL ); however, treatment resistance remains a problem. Ublituximab is a novel, glycoengineered anti‐ CD 20 monoclonal antibody with single‐agent activity in relapsed CLL . We report the results of a phase 2 study evaluating combination therapy with ibrutinib and ublituximab in patients with relapsed or refractory CLL . Patients received ibrutinib 420 mg once daily. Ublituximab was administered on days 1, 8 and 15 of cycle 1 followed by day 1 of cycles 2–6. Response assessments were completed at cycles 3 and 6; patients then continued on ibrutinib monotherapy per standard of care. Forty‐one of 45 enrolled patients were evaluable for efficacy. Safety was consistent with prior experience for each drug, with infusion reactions the most prevalent adverse event. Combination therapy resulted in an overall response rate ( ORR ) of 88% at 6 months. In the 20 patients with high‐risk features (17p or 11q deletions or TP 53 mutation) and evaluable for efficacy, the ORR was 95%, with three patients (15%) achieving negative minimal residual disease. Median time to response was 8 weeks. Ublituximab in combination with ibrutinib resulted in rapid and high response rates. The long‐term clinical benefit of ublituximab will be defined by an ongoing phase 3 trial ( NCT 02301156).