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Positive topline results announced from the UNITY-CLL study evaluating the combination of umbralisib and ublituximab (U2) for the treatment of CLL

May 12, 2020
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On May 5, 2020, positive topline results were announced from the phase III global UNITY-CLL trial (NCT02612311). The trial evaluated the efficacy of the combination of umbralisib plus ublituximab (U2) compared with obinutuzumab plus chlorambucil in patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia (CLL). This trial met its primary endpoint at the interim analysis and demonstrated a statistically significant improvement in progression-free survival (PFS; p < 0.0001). The PFS benefit was observed in both previously untreated and relapsed/refractory patients. The study will be stopped early due to the superior efficacy observed at this interim analysis.1

Secondary endpoints of the study, such as safety, have not been reported yet.

To read the Lymphoma Hub’s previous coverage on the UNITY-CLL trial click here.

  1. 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. http://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-announces-positive-topline-results-unity-cll. Published May 5, 2020. Accessed May 11, 2020.

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