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Phase 2 multicentre study of single-agent ofatumumab in previously untreated follicular lymphoma: CALGB 50901 (Alliance)

British Journal of Haematology Feb 11, 2019

Rosenbaum CA, et al. - In 51 patients with untreated, low/intermediate-risk follicular lymphoma (FL) International Prognostic Index (FLIPI), advanced-stage FL, researchers assessed the efficacy of single-agent ofatumumab (a fully humanized anti-CD20 monoclonal antibody with increased CD20 affinity and complement-dependent cytotoxicity). Four weekly 1000 mg doses followed by four extended induction doses once every 8 weeks were administered in patients with measurable disease in stages III/IV or bulky stage II, irrespective of Groupe d'Etude des Lymphomes Folliculaires criteria. They randomized 15 patients to 500 mg prior to discontinuing that arm for slow accrual. Overall response rate (ORR) of 84%, median progression-free survival (PFS) of 1·9 years and median response duration of 23·7 months were reported for 36 patients on the 1000 mg arm. Grade 4 infusion reactions or grade 3/4 infections did not occur. In 25% in the 1000 mg arm only (all first infusion), the occurrence of grade 3 infusion reactions was noted. Overall, good tolerability, as well as the activity of ofatumumab monotherapy, was observed when administered by extended induction in untreated, low/intermediate-risk FLIPI, advanced-stage FL. Compared with single-agent rituximab, a similar activity was seen.
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