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Ofatumumab is a fully humanized anti\u2010<jats:styled-content style=\"fixed-case\">CD<\/jats:styled-content>20 monoclonal antibody with increased <jats:styled-content style=\"fixed-case\">CD<\/jats:styled-content>20 affinity and complement\u2010dependent cytotoxicity. This phase 2 trial (<jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>01190449) evaluated ofatumumab in patients with untreated, low\/intermediate\u2010risk FL International Prognostic Index (<jats:styled-content style=\"fixed-case\">FLIPI<\/jats:styled-content>), advanced\u2010stage <jats:styled-content style=\"fixed-case\">FL<\/jats:styled-content> to determine single\u2010agent efficacy. Patients with measurable disease in stages <jats:styled-content style=\"fixed-case\">III<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">IV<\/jats:styled-content> or bulky stage <jats:styled-content style=\"fixed-case\">II<\/jats:styled-content>, regardless of Groupe d'Etude des Lymphomes Folliculaires criteria, received 4 weekly 1000\u00a0mg doses followed by four extended induction doses once every 8\u00a0weeks. Primary endpoint was overall response rate (<jats:styled-content style=\"fixed-case\">ORR<\/jats:styled-content>) to 1000\u00a0mg; secondary endpoints were progression\u2010free survival (<jats:styled-content style=\"fixed-case\">PFS<\/jats:styled-content>) and safety. Fifty\u2010one patients were enrolled. Fifteen patients were randomized to 500\u00a0mg prior to discontinuing that arm for slow accrual. Among 36 patients on the 1000\u00a0mg arm, <jats:styled-content style=\"fixed-case\">ORR<\/jats:styled-content> was 84%, median <jats:styled-content style=\"fixed-case\">PFS<\/jats:styled-content> was 1\u00b79\u00a0years and median response duration was 23\u00b77\u00a0months. All patients remain alive. No grade 4 infusion reactions or grade 3\/4 infections occurred. Grade 3 infusion reactions occurred in 25% in the 1000\u00a0mg arm only (all first infusion); all but two patients continued on study. Discontinuation was 6% for the total study population. Ofatumumab monotherapy administered by extended induction in untreated, low\/intermediate\u2010risk <jats:styled-content style=\"fixed-case\">FLIPI<\/jats:styled-content>, advanced\u2010stage <jats:styled-content style=\"fixed-case\">FL<\/jats:styled-content> is well tolerated and active. 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