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news.TG Therapeutics has signed a special protocol assessment agreement with the US Food and Drug Administration (FDA) for the first phase 3 clinical trial of its combination regimen of TG-1101 (ublituximab) in combination with TGR-1202 for patients with chronic lymphocytic leukemia (CLL).
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Under the deal, if the company meets Phase 3 trial design objectives, it can seek regulatory approval of both TG-1101 and TGR-1202 in combination.
The company will release the full details of the Phase 3 clinical trial, dubbed the UNITY-CLL, at the launch of the study.
The randomized controlled clinical trial will demonstrate contribution of each agent in the TG-1101 + TGR-1202 regimen.
It will also evaluate superiority in progression free survival (PFS) over the standard of care to support the submission for full approval of the combination.
Patients will be randomized into four treatment arms such as TG-1101 + TGR-1202, TG-1101 alone, TGR-1202 alone, and an active control arm of obinutuzumab + chlorambucil.
An early interim analysis will assess contribution of each single agent in the TG-1101 + TGR-1202 combination regimen, which, if successful, will enable early termination of both single agent arms.
The company will carry out a second interim analysis after full enrollment into the study. If positive, the company aims to use for accelerated approval.
About 450 patients will be enrolled in the study, assuming early termination of the TG-1101 and TGR-1202 single agent arms.
TG Therapeutics executive chairman and interim CEO Michael Weiss said: "The UNITY-CLL study and the related SPA marks a major milestone for the Company and, if successful, could lead to a very broad label in the treatment of CLL, providing patients and physicians a new treatment option, and the Company a platform to build additional proprietary combinations in our continued effort to drive towards a cure."