TG Therapeutics (NASDAQ:TGTX) is up 5% premarket on light volume on the heels of positive preliminary data from a Phase 2b clinical trial, UNITY-NHL, evaluating umbralisib, with or without bendamustine and TGR-1202 alone in treatment-naive patients with non-Hodgkin lymphoma. One arm is assessing umbralisib as monotherapy in patients with relapsed or refractory marginal zone lymphoma (MZL). The results from the MZL group were presented at the AACR conference in Atlanta.
The overall response rate (ORR) (median follow-up of 12.5 months) was 52% (n=22/42), including eight complete responders.
The clinical benefit rate (responders + stable cancer), also commonly referred to as the disease control rate (DCR), was 88% (n=37/42). 86% of treated patients experienced reductions in tumor burden. Median progression-free survival (PFS) has not been reached.
No new safety signals were observed.
Final data from the MZL cohort should be available later this year. The company expects to file a U.S. marketing application seeking accelerated approval by year-end.
Management will host a conference call today at 12:00 pm ET to discuss the results.
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