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Phase 2 multicentre study of single‐agent ofatumumab in previously untreated follicular lymphoma: CALGB 50901 (Alliance)
Author(s) -
Rosenbaum Cara A.,
Jung SinHo,
Pitcher Brandelyn,
Bartlett Nancy L.,
Smith Sonali M.,
Hsi Eric,
WagnerJohnston Nina,
Thomas Sachdev P.,
Leonard John P.,
Cheson Bruce D.
Publication year - 2019
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.15768
Subject(s) - medicine , ofatumumab , rituximab , neutropenia , gastroenterology , clinical endpoint , surgery , discontinuation , phases of clinical research , follicular lymphoma , population , febrile neutropenia , lymphoma , randomized controlled trial , chemotherapy , environmental health
Summary Rituximab monotherapy has proven efficacy in treatment‐naïve, asymptomatic advanced‐stage follicular lymphoma ( FL ). Ofatumumab is a fully humanized anti‐ CD 20 monoclonal antibody with increased CD 20 affinity and complement‐dependent cytotoxicity. This phase 2 trial ( NCT 01190449) evaluated ofatumumab in patients with untreated, low/intermediate‐risk FL International Prognostic Index ( FLIPI ), advanced‐stage FL to determine single‐agent efficacy. Patients with measurable disease in stages III / IV or bulky stage II , regardless of Groupe d'Etude des Lymphomes Folliculaires criteria, received 4 weekly 1000 mg doses followed by four extended induction doses once every 8 weeks. Primary endpoint was overall response rate ( ORR ) to 1000 mg; secondary endpoints were progression‐free survival ( PFS ) and safety. Fifty‐one patients were enrolled. Fifteen patients were randomized to 500 mg prior to discontinuing that arm for slow accrual. Among 36 patients on the 1000 mg arm, ORR was 84%, median PFS was 1·9 years and median response duration was 23·7 months. 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 mg 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‐risk FLIPI , advanced‐stage FL is well tolerated and active. Activity appears similar to that reported with single‐agent rituximab.