Heading into 2019, the pivotal UNITY-NHL will be of upmost importance for TG Therapeutics
(TGTX) as it moves closer to transitioning into a commercial phase company. The trial is now fully
enrolled, and the company expects a top-line ORR release for the marginal zone lymphoma (MZL)
and follicular lymphoma (FL) cohorts mid-2019, with a potential NDA filing in 2H 2019. Look for
further updates from UNITY-NHL at the end of the year, at ASH 2019. In addition, the UNITY-CLL
trial, also testing the ublituximab/umbralisib (“U2”) combination but in chronic lymphocytic
leukemia, is making good progress, with enrollment complete and a top-line PFS readout
expected in 2H 2019.
Looking ahead, the excellent tolerability profile of umbralisib compared to other PI3K inhibitors
enables the drug to be developed in various other combinations. For example, TG Therapeutics
announced that a Phase Ib in hematological cancers will begin in Q1 2019, testing U2 in
combination with TG-1501, the company’s proprietary PD-L1 inhibitor. In addition, U2 is being
tested with the company’s BTK inhibitor TG-1701 in mantle cell lymphoma and Waldenstrom’s
macroglobulinemia. The company also suggested further trials featuring U2-based triple and
quadruple combinations may be on the horizon.
TG Therapeutics concluded the talk by discussing its Phase III ULTIMATE trial testing ublituximab
in multiple sclerosis. This pivotal trial is also fully enrolled, and an initial data release is currently
slated for mid-2020.
(TGTX) as it moves closer to transitioning into a commercial phase company. The trial is now fully
enrolled, and the company expects a top-line ORR release for the marginal zone lymphoma (MZL)
and follicular lymphoma (FL) cohorts mid-2019, with a potential NDA filing in 2H 2019. Look for
further updates from UNITY-NHL at the end of the year, at ASH 2019. In addition, the UNITY-CLL
trial, also testing the ublituximab/umbralisib (“U2”) combination but in chronic lymphocytic
leukemia, is making good progress, with enrollment complete and a top-line PFS readout
expected in 2H 2019.
Looking ahead, the excellent tolerability profile of umbralisib compared to other PI3K inhibitors
enables the drug to be developed in various other combinations. For example, TG Therapeutics
announced that a Phase Ib in hematological cancers will begin in Q1 2019, testing U2 in
combination with TG-1501, the company’s proprietary PD-L1 inhibitor. In addition, U2 is being
tested with the company’s BTK inhibitor TG-1701 in mantle cell lymphoma and Waldenstrom’s
macroglobulinemia. The company also suggested further trials featuring U2-based triple and
quadruple combinations may be on the horizon.
TG Therapeutics concluded the talk by discussing its Phase III ULTIMATE trial testing ublituximab
in multiple sclerosis. This pivotal trial is also fully enrolled, and an initial data release is currently
slated for mid-2020.
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