Ofatumumab monotherapy in rituximab-refractory follicular lymphoma: results from a multicenter study.

Abstract

New treatments are required for rituximab-refractory follicular lymphoma (FL). In the present study, patients with rituximab-refractory FL received 8 weekly infusions of ofatumumab (CD20 mAb; dose 1, 300 mg and doses 2-8, 500 or 1000 mg; N = 116). The median age of these patients was 61 years, 47% had high-risk Follicular Lymphoma International Prognostic Index scores, 65% were chemotherapy-refractory, and the median number of prior therapies was 4. The overall response rate was 13% and 10% for the 500-mg and 1000-mg arms, respectively. Among 27 patients refractory to rituximab monotherapy, the overall response rate was 22%. The median progression-free survival was 5.8 months. Forty-six percent of patients demonstrated tumor reduction 3 months after therapy initiation, and the median progression-free survival for these patients was 9.1 months. The most common adverse events included infections, rash, urticaria, fatigue, and pruritus. Three patients experienced grade 3 infusion-related reactions, none of which were considered serious events. Grade 3-4 neutropenia, leukopenia, anemia, and thrombocytopenia occurred in a subset of patients. Ofatumumab was well tolerated and modestly active in this heavily pretreated, rituximab-refractory population and is therefore now being studied in less refractory FL and in combination with other agents in various B-cell neoplasms. The present study was registered at www.clinicaltrials.gov as NCT00394836.

• Authors: Myron S Czuczman, Luis Fayad, Vincent Delwail, Guillaume Cartron, Eric Jacobsen, Kazimierz Kuliczkowski, Brian K Link, Lauren Pinter-Brown, John Radford, Andrzej Hellmann, Eve Gallop-Evans, Christine G DiRienzo, Nancy Goldstein, Ira Gupta, Roxanne C Jewell, Thomas S Lin, Steen Lisby, Martin Schultz, Charlotte A Russell, Anton Hagenbeek, 405 Study Investigators
• Journal: Blood (Blood) Vol. 119 Issue 16 Pg. 3698-704 (Apr 19 2012) ISSN: 1528-0020 [Electronic] United States
• PMID: 22389254 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Antibodies, Monoclonal, Murine-Derived
• Antineoplastic Agents
• Rituximab
• ofatumumab

Topics

• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal (administration & dosage, adverse effects, pharmacokinetics)
• Antibodies, Monoclonal, Humanized
• Antibodies, Monoclonal, Murine-Derived (immunology, therapeutic use)
• Antineoplastic Agents (immunology, therapeutic use)
• B-Lymphocytes (drug effects, immunology)
• Disease-Free Survival
• Drug Resistance, Neoplasm (immunology)
• Humans
• Lymphoma, Follicular (drug therapy, immunology)
• Middle Aged
• Prognosis
• Prospective Studies
• Rituximab