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Updated data from a Phase 2 study evaluating TG Therapeutics' (TGTX +17.6%) investigational TG-1101 (ublituximab) in combination with ibrutinib (Pharmacyclics' (NYSE:ABBV) Imbruvica) in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) showed a 95% overall response rate (n=19/20) with 20% (n=4/20) achieving MRD (minimal residual disease) negativity in CLL patients considered high risk. The data were presented at the 13th International Congress on Malignant Lymphoma in Lugano, Switzerland.
- In 40 evaluable patients, 88% (n=35/40) achieved an objective response and 10% (n=4/40) achieved nodal reductions of 20 - 55% without disease progression.
- The combination of TG-1101 and ibrutinib was well tolerated in the 44 patients treated. The most common Grade 3 or 4 (severe/life threatening) adverse events observed were neutropenia (11%) (n=5/44), anemia (11%) (n=5/44) and infusion-related reactions (7%) (n=3/44).
- A Phase 3 study, called GENUINE, comparing the combination of TG-1101 and ibrutinib to ibrutinib alone in previously-treated high risk CLL patients is underway. Total enrollment will be ~330. Results will support a Biologics License Application (BLA) for accelerated approval of TG-1101. The study's completion date is projected to be August 2018.