TG Therapeutics announced the publication of results from the multicenter Phase 1 triple combination trial of ublituximab, the company’s anti-CD20 monoclonal antibody, umbralisib, the company’s oral once-daily PI3K delta inhibitor and ibrutinib, the oral Bruton’s tyrosine kinase inhibitor, in The Lancet Haematology. The paper includes safety and efficacy information from patients with relapsed or refractory B-cell malignancies, including 23 patients with chronic lymphocytic leukemia, or CLL, or small lymphocytic lymphoma, or SLL, and 23 patients with non-Hodgkin lymphoma, or NHL. Safety data was available from all 46 patients and the triple combination of ublituximab, umbralisib, and ibrutinib was well tolerated with a manageable adverse event profile, and no maximum tolerated dose achieved for the combination. Efficacy data was available from 44 patients and showed the triple combination to be highly active. The overall response rate, or ORR, amongst all evaluable patients was 84%, with 100% of patients with CLL/SLL achieving a response, including 36% achieving a complete response, or CR. Among patients with NHL, 68% achieved a response, including a 71% ORR in follicular lymphoma, a 100% ORR in marginal zone lymphoma and a 100% ORR in mantle cell lymphoma.
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