Ublituximab (TG-1101), a novel glycoengineered anti-CD20 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.

Autor: Sharman JP; Willamette Valley Cancer Institute, Springfield, OR, USA.; US Oncology Research, Morristown, NJ, USA., Farber CM; Carol G. Simon Cancer Center, Morristown, NJ, USA., Mahadevan D; West Cancer Center/University of Tennessee Health Science Center, Memphis, TN, USA., Schreeder MT; Clearview Cancer Institute, Huntsville, AL, USA., Brooks HD; US Oncology Research, Morristown, NJ, USA.; Blue Ridge Cancer Care, Blacksburg, VA, USA., Kolibaba KS; US Oncology Research, Morristown, NJ, USA.; Compass Oncology, Vancouver, WA, USA., Fanning S; US Oncology Research, Morristown, NJ, USA.; Greenville Health System Cancer Institute, Greenville, SC, USA., Klein L; US Oncology Research, Morristown, NJ, USA.; Illinois Cancer Specialists, Niles, IL, USA., Greenwald DR; US Oncology Research, Morristown, NJ, USA.; Cancer Center of Santa Barbara, Santa Barbara, CA, USA., Sportelli P; TG Therapeutics, Inc., New York, NY, USA., Miskin HP; TG Therapeutics, Inc., New York, NY, USA., Weiss MS; TG Therapeutics, Inc., New York, NY, USA., Burke JM; US Oncology Research, Morristown, NJ, USA.; Rocky Mountain Cancer Centers, Aurora, CO, USA.
Jazyk: angličtina
Zdroj: British journal of haematology [Br J Haematol] 2017 Feb; Vol. 176 (3), pp. 412-420. Date of Electronic Publication: 2016 Dec 16.
DOI: 10.1111/bjh.14447
Abstrakt: Ibrutinib is effective in patients with chronic lymphocytic leukaemia (CLL); however, treatment resistance remains a problem. Ublituximab is a novel, glycoengineered anti-CD20 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 TP53 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).
(© 2016 The Authors. British Journal of Haematology published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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