Date: 2015-09-09
Type of
information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
Company: TG Therapeutics (USA - NY)
Product: TG-1101 (ublituximab), TGR-1202 and pembrolizumab
Action
mechanism:
- monoclonal antibody/immune checkpoint inhibitor/phosphoinositide 3-kinase (PI3K) inhibitor
- Keytruda® (pembrolizumab - MK-3475) is a selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system. Pembrolizumab is being evaluated across more than 30 types of cancers, as monotherapy and in combination. Keytruda® is the first approved drug that blocks the PD-1 cellular pathway.
- TG-1101 (ublituximab) is a monoclonal antibody that targets a unique epitope on the B-lymphocyte CD20 antigen.
- TGR-1202 (formerly known as RP5264) is an orally available PI3K delta inhibitor, targeting the delta isoform with nanomolar potency and several fold selectivity over the alpha, beta, and gamma isoforms of phosphoinositide 3-kinase. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B-cell lymphocytes. Inhibition of PI3K delta signaling with TGR-1202 has demonstrated robust activity in numerous pre-clinical models and primary cells from patients with hematologic malignancies.
Disease: chronic lymphocytic leukemia
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
- This phase I/II study evaluates the safety and effectiveness of pembrolizumab in combination with ublituximab and TGR-1202, in patients with advanced chronic lymphocytic leukemia (CLL). (NCT02535286)
Latest
news:
- • On September 9, 2015, TG Therapeutics announced the initiation of a Phase 1/2 clinical study that will investigate the use of TGR-1202, the Company's oral PI3K delta inhibitor and TG-1101 (ublituximab), the Company's glycoengineered anti-CD20 monoclonal antibody in combination with pembrolizumab the anti-PD-1 immune checkpoint inhibitor, in patients with relapsed or refractory CLL. This will be the first clinical trial evaluating the safety, tolerability and effectiveness of the triple combination of a PI3K delta inhibitor with an anti-CD20 mAb and an anti-PD-1 checkpoint inhibitor.
- Dr. Anthony Mato, an assistant professor in the Perelman School of Medicine at the University of Pennsylvania, Director of the Center for CLL at Penn's Abramson Cancer Center and Study Chair of the Phase 1/2 study added, "We look forward to collaborating with TG Therapeutics on this novel combination clinical trial. Our center has been intimately involved with T-cell therapies for hematologic diseases and we are firm believers in the promise they hold broadly for cancer patients. The combination of TG-1101 and TGR-1202 has demonstrated unique tolerability and activity which we believe represents a strong backbone on which to add additional novel therapies. We believe the novel approach utilized in this study, where we will induce a response with TG-1101 and TGR-1202, followed by consolidation with anti-PD-1 therapy, could maximize the potential benefit of T-cell therapy in CLL. We are thrilled to have moved this study from concept to first patient enrolled in just a few months, and look forward to offering patients with advanced CLL new options with this novel triple combination."
- The Phase 1 part of the study will evaluate the safety, tolerability, and appropriate dose of pembrolizumab when combined with TGR-1202 and TG-1101 in patients with advanced CLL. The Phase 2 part of the study will further evaluate the safety and effectiveness of the triple combination at the recommended Phase 2 dose.
Is
general: Yes
