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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
- Source :
- British journal of haematology. 176(3)
- Publication Year :
- 2016
-
Abstract
- Summary 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).
- Subjects :
- 0301 basic medicine
Drug
Oncology
Adult
Male
medicine.medical_specialty
Combination therapy
media_common.quotation_subject
Phases of clinical research
Pharmacology
Protein Engineering
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Refractory
Piperidines
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
In patient
Adverse effect
media_common
Aged
Aged, 80 and over
Salvage Therapy
business.industry
Adenine
Antibodies, Monoclonal
Hematology
Middle Aged
Antigens, CD20
Minimal residual disease
Leukemia, Lymphocytic, Chronic, B-Cell
030104 developmental biology
Pyrimidines
Treatment Outcome
chemistry
030220 oncology & carcinogenesis
Ibrutinib
Pyrazoles
Female
business
Subjects
Details
- ISSN :
- 13652141 and 02301156
- Volume :
- 176
- Issue :
- 3
- Database :
- OpenAIRE
- Journal :
- British journal of haematology
- Accession number :
- edsair.doi.dedup.....d83fbadd6679ff76a1721c77ac583590