TG Therapeutics (NASDAQ:TGTX) is up 24% premarket on light volume on the heels of positive results from a Phase 1/2 clinical trial evaluating the combination of ublituximab, umbralisib (U2) and venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). The data were presented at ASH in Orlando.
• The overall response rate (ORR) in evaluable patients was 87% (n=20/23) after U2 induction period at cycle 3, prior to treatment with venetoclax, including patients who failed to respond to AbbVie's (NYSE:ABBV) Imbruvica (ibrutinib). The ORR was 100% (n=13/13) after cycle 7 of the triple combo.
• U2 induction appeared to reduce the risk of tumor lysis syndrome (a large number of cancer cells die within a short period, releasing their contents in the blood, depressing calcium levels affecting the function of certain organs) associated with venetoclax.
• Ublituximab is an anti-CD20 monoclonal antibody. Umbralisib is a dual PI3K delta and CK1 epsilon inhibitor. Venetoclax, marketed as Venclexta by AbbVie and Roche (OTCQX:RHHBY), is a BCL-2 inhibitor.
• Data from a Phase 3 study, UNITY-CLL, comparing U2 to Roche's Gazyva (obinutuzumab) + chemo agent chlorambucil should be available in the coming months.
• #ASH19
