Ofatumumab-based consolidation therapy appears to be efficacious for and well-tolerated by patients with chronic lymphocytic leukemia (CLL), according to study published in the journal The Lancet Haematology.1
Ofatumumab, a human type I anti-CD20 monoclonal antibody, is approved by the U.S. Food and Drug Administration as maintenance therapy for patients with recurrent or progressive CLL who have achieved a complete or partial response after at least 2 lines of treatment. Researchers assessed whether efficacy could be improved if ofatumumab were used as a consolidation strategy.
For this phase 2 study, investigators enrolled patients with previously untreated CLL and assigned them to 1 of 2 treatment arms. In the first arm, which was previously reported, patients received 6 cycles of induction with pentostatin 2 mg/m2 on day 1, cyclophosphamide 600 mg/m2 on day 1, and ofatumumab intravenously every 21 days. During cycle 1, ofatumumab was administered at a dose of 300 mg on day 1 and 1000 mg/m2 on day 2, followed by 1000 mg/m2 on day 1 during cycles 2 to 6.
In the second arm, 34 patients received the same regimen as in the first arm, in addition to 6 cycles of ofatumumab consolidation at a dose of 1000 mg intravenously once every 4 weeks.
Thirty-one of the 34 patients completed induction and started consolidation, and 26 patients completed the 6 planned cycles of ofatumumab consolidation. The 18-month treatment-free survival rate was 94.1% (95% CI, 78.5-98.5).
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Grade 3 or worse adverse events at least potentially related to ofatumumab consolidation were neutropenia (41%), infection (6%), anemia (3%), hemolysis (3%), fatigue (3%), and a neurologic, metabolic, respiratory, and vascular complication (each in 3%).
- Strati P, Lanasa M, Call TG, et al. Ofatumumab monotherapy as a consolidation strategy in patients with previously untreated chronic lymphocytic leukaemia: a phase 2 trial. Lancet Haematol. 2016 Aug 1. doi: 10.1016/S2352-3026(16)30064-3 [Epub ahead of print]