TG Therapeutics Announces Positive Topline Results

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TG Therapeutics Announces Positive Topline Results from the UNITY-CLL Phase 3 Study Evaluating the Combination of Umbralisib and Ublituximab (U2) for the Treatment of Patients with Chronic Lymphocytic Leukemia

Umbralisib is a PI3k inhibitor, as are idelalisib and duvelisib. PI3k is a very important pathway in CLL and blocking it can offer strong disease control, although there have been side effects associated with these drugs that were especially pronounced when idelalisib was administered as a first line therapy.

It appears that umbralisib has a different safety profile and as shown in this trial, it may offer for the first time what we hope will prove to be a safe and effective use of a PI3k Inhibitor in treatment-naïve CLL patients.

It was combined with TG Therapeutics’ own 3^rd generation monoclonal antibody (MAB) ublituximab that targets CD20 and may be similar to the potent, MAB obinutuzumab (Gazyva).

We know that this “U2” combination of umbralisib and ublituximab is significantly superior to chlorambucil plus obinutuzumab in terms of progression free survival (PFS)

Quoting from the press release: “The trial met its primary endpoint at a prespecified interim analysis demonstrating a statistically significant improvement in progression-free survival (PFS) (p<.0001), and will be stopped early for superior efficacy.”

Sadly, we have no other data on the side effects or even on the “superior efficacy”. We will have to wait, likely until ASH 2020 in December for more information.

CLL research is heading decidedly in the direction of combination therapies, and this study adds 2 more drugs to the mix under consideration.

Here is the link to the press release.