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

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.