The U.S. Food and Drug Administration (FDA) has designated the combination of TG-1101 and TGR-1202 an Orphan Drug as a potential treatment for diffuse large B-cell lymphoma (DLBCL).
The combination recently received Orphan Drug designation for the treatment of chronic lymphocytic leukemia (CLL).
Orphan Drug status is given to therapies intended to treat diseases affecting fewer than 200,000 people in the U.S., and it involves financial incentives, among others, that encourage and accelerate their development.
“We are pleased to receive orphan drug designation for our proprietary combination of TG-1101 and TGR-1202 in diffuse large B-cell lymphoma,” Michael S. Weiss, executive chairman and chief executive officer of TG Therapeutics, said in a news release. “DLBCL is an area of significant unmet medical need and we are highly encouraged by the early clinical data we have seen in DLBCL patients treated with 1101 plus 1202 and look forward to evaluating this further in our ongoing Phase 2b registration directed trial.”
The Phase 2b, randomized, open-label trial, called UNITY-DLBCL (NCT02793583), will test the combination in people with previously treated relapsed or refractory DLBCL. Researchers will assess the therapy’s safety and efficacy, versus TGR-1202 alone, in up to 200 patients at 35 U.S. test sites. The study’s primary focus will be overall response rate, and time to disease progression will be assessed as a secondary endpoint.
Participants older than 18 are being enrolled.
TG-1101 (ublituximab) is a monoclonal antibody that targets the CD20 protein — found at the surface of most leukemia and lymphoma cells — to induce strong immune responses against these cells.
TGR-1202 is an orally available PI3K delta inhibitor. PI3K is highly expressed in cells of hematopoietic (blood cell) origin, and is believed to be important in the proliferation and survival of B-cell lymphocytes.
According to estimates from the American Cancer Society, diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma in the United states, affecting 1 out of every 3 patients. The cancer affects B-cells, which are a subtype of immune cells, and it mainly occurs in older people.
Although it is described as a fast-growing, or aggressive, lymphoma, patients often respond well to treatment.
