Clinical Trials

Date: 2016-12-16

Type of information: Publication of results in a medical journal

phase: 2

Announcement: publication of results in the British Journal of Haematology

Company: TG Therapeutics (USA - NY)

Product: TG-1101 (ublituximab) and ibrutinib

Action mechanism:

monoclonal antibody/Bruton tyrosine kinase inhibitor. Ibrutinib is a novel Bruton’s tyrosine kinase (BTK) inhibitor being jointly developed by Janssen and Pharmacyclics, Inc. for the treatment of B-cell malignancies. Ibrutinib is jointly developed and commercialized in the United States by Pharmacyclics and Janssen Biotech, Inc. In Europe, Janssen-Cilag International NV (Janssen) holds the marketing authorization and its affiliates market Imbruvica® in EMEA (Europe, Middle East, Africa), as well as the rest of the world. Imbruvica® is already approved in Europe to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) and adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy or in first line use in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. In March 2015, Abbvie and Pharmacyclics announced a definitive agreement under which AbbVie will acquire Pharmacyclics, and its flagship asset Imbruvica® (ibrutinib).
TG-1101 (ublituximab) is a monoclonal antibody that targets a unique epitope on the B-lymphocyte CD20 antigen.

Disease: chronic lymphocytic leukemia (CLL)

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

• On December 16, 2016, TG Therapeutics announced the publication of clinical data from a Phase 2 study of TG-1101 (ublituximab) in combination with ibrutinib in patients with chronic lymphocytic leukemia (CLL). The data, which was presented at the 2015 International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland , demonstrates the combination to be well tolerated with limited grade 3/4 adverse events observed. An 88% overall response rate (ORR) was reported at month 6 for all patients treated, with a 95% ORR observed in patients with high risk CLL (presence of a 17p or 11q deletion or a TP53 mutation). These data are described further in the manuscript titled, "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 leukemia: results of a phase 2 trial," which is published in the British Journal of Haematology .