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TGT Starts CLL, MCL Trial

Will test combo of anti-CD20 MAb with Janssen/Pharmacyclics' Imbruvica

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

TG Therapeutics has begun a multi-center Phase II trial to evaluate the safety and efficacy of the combination of TG-1101 (ublituximab) and Imbruvica (ibrutinib) for patients with Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL). This will be the first clinical trial evaluating the combination of TG-1101, the company’s novel glycoengineered anti-CD20 monoclonal antibody, and ibrutinib, the oral Bruton Tyrosine Kinase (BTK) inhibitor which was recently granted approval by the FDA for Janssen and Pharmacyclics.

The trial will enroll patients with CLL and MCL who are eligible to receive ibrutinib. TG Therapeutics has partnered with the US Oncology Network, Columbia University and other select centers throughout the U.S. on the study. Jeff Sharman, MD, Medical Director for Hematology Research, US Oncology Network, will be the Study Chair for the CLL patient group, while Owen A. O’Connor, MD, PhD, Professor and Director of the Center for Lymphoid Malignancies, Columbia University Medical Center will be the Study Chair for the MCL patient group.

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