@article{da05d86638b149bd8eea74ca97a4b6a5,
title = "Phase 2 multicentre study of single-agent ofatumumab in previously untreated follicular lymphoma: CALGB 50901 (Alliance)",
abstract = "Rituximab monotherapy has proven efficacy in treatment-na{\"i}ve, asymptomatic advanced-stage follicular lymphoma (FL). Ofatumumab is a fully humanized anti-CD20 monoclonal antibody with increased CD20 affinity and complement-dependent cytotoxicity. This phase 2 trial (NCT01190449) 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.",
keywords = "follicular lymphoma, immunotherapy, monoclonal antibody, ofatumumab, previously untreated",
author = "Rosenbaum, {Cara A.} and Jung, {Sin Ho} and Brandelyn Pitcher and Bartlett, {Nancy L.} and Smith, {Sonali M.} and Eric Hsi and Nina Wagner-Johnston and Thomas, {Sachdev P.} and Leonard, {John P.} and Cheson, {Bruce D.}",
note = "Funding Information: The authors acknowledge the investigators from the participating Alliance institutions for their participation, the Cancer Therapy Evaluation Program and Novartis Corporation. Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under Award Numbers U10CA180821 and U10CA180882 (to the Alliance for Clinical Trials in Oncology), U10CA180833, U10CA180836, U10CA180857, and UG1CA189830. Ofatumumab was provided by GlaxoSmithKline. The following institutional networks participated in this study: Dana-Farber/Partners Cancer Care LAPS, Boston, MA, Harold Burstein, U10CA180867; Delaware/Christiana Care NCI Community Oncology Research Program, Newark, DE, Gregory Masters, UG1CA189819; Heartland Cancer Research NCORP, Decatur, IL, James Wade, UG1CA189830; MedStar Georgetown University Hospital, Washington, DC, Chaitra Ujjani; New Hampshire Oncology Hematology PA-Hooksett, Hooksett, NH, Douglas Weckstein; The Ohio State University Comprehensive Cancer Center LAPS, Columbus, OH, Clara Bloomfield, U10CA180850; UNC Lineberger Comprehensive Cancer Center LAPS, Chapel Hill, NC, Thomas Shea, U10CA180838; University of Chicago Comprehensive Cancer Center LAPS, Chicago, IL, Hedy Kindler, U10CA180836; University of Iowa/Holden Comprehensive Cancer Center, Iowa City, IA, Laith Abushahin; VCU Massey Cancer Center Minority Underserved NCORP, Richmond, VA, Steven Grossman, UG1CA189869; Wake Forest University Health Sciences, Winston-Salem, NC, Heidi Klepin; Washington University ? Siteman Cancer Center LAPS, Saint Louis, MO, Nancy Bartlett, U10CA180833; and Weill Medical College of Cornell University, New York, NY, Scott Tagawa. Funding Information: The authors acknowledge the investigators from the participating Alliance institutions for their participation, the Cancer Therapy Evaluation Program and Novartis Corporation. Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under Award Numbers U10CA180821 and U10CA180882 (to the Alliance for Clinical Trials in Oncology), U10CA180833, U10CA180836, U10CA180857, and UG1CA189830. Ofatu-mumab was provided by GlaxoSmithKline. Publisher Copyright: {\textcopyright} 2019 British Society for Haematology and John Wiley & Sons Ltd",
year = "2019",
month = apr,
doi = "10.1111/bjh.15768",
language = "English",
volume = "185",
pages = "53--64",
journal = "British Journal of Haematology",
issn = "0007-1048",
number = "1",
}