A multicentre, phase II trial of ofatumumab monotherapy in relapsed/progressive diffuse large B-cell lymphoma

Coiffier, Bertrand; Radford, John; Bosly, André; Martinelli, Giovanni; Barca, Gabriela; Davies, Andrew; Decaudin, Didier; Gallop-Evans, Eve; Padmanabhan-Iyer, Swaminathan; Van Eygen, Koen; Wu, Ka Lung; Gupta, Ira V; Lin, Thomas S; Goldstein, Nancy; Jewell, Roxanne C; Winter, Paul; Lisby, Steen; 415 study investigators,; Verhoef, Gregor

doi:10.1111/bjh.12537

A multicentre, phase II trial of ofatumumab monotherapy in relapsed/progressive diffuse large B-cell lymphoma

Author:

Coiffier, Bertrand

Radford, John ; Bosly, André ; Martinelli, Giovanni ; Barca, Gabriela ; Davies, Andrew ; Decaudin, Didier ; Gallop-Evans, Eve ; Padmanabhan-Iyer, Swaminathan ; Van Eygen, Koen ; Wu, Ka Lung ; Gupta, Ira V ; Lin, Thomas S ; Goldstein, Nancy ; Jewell, Roxanne C ; Winter, Paul ; Lisby, Steen ; 415 study investigators, ; Verhoef, Gregor

Keywords:

Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antibodies, Monoclonal, Murine-Derived, Antigens, CD20, Antineoplastic Agents, Antineoplastic Agents, Alkylating, Antineoplastic Combined Chemotherapy Protocols, Combined Modality Therapy, Disease-Free Survival, Drug Resistance, Neoplasm, Female, Hematologic Diseases, Hematopoietic Stem Cell Transplantation, Humans, Immunotherapy, Kaplan-Meier Estimate, Lymphoma, Large B-Cell, Diffuse, Male, Middle Aged, Recurrence, Remission Induction, Salvage Therapy, Young Adult, Science & Technology, Life Sciences & Biomedicine, Hematology, haematological malignancies, immunotherapy, lymphoid malignancies, non-Hodgkin lymphoma, diffuse large B-cell lymphoma, REFRACTORY FOLLICULAR LYMPHOMA, ANTI-CD20 MONOCLONAL-ANTIBODY, ELDERLY-PATIENTS, RITUXIMAB, CHOP, CD20, Antibodies, Monoclonal, Humanized, Rituximab, 415 study investigators, 1102 Cardiorespiratory Medicine and Haematology, Immunology, 3201 Cardiovascular medicine and haematology

Abstract:

This international, multicentre phase II study was conducted to assess ofatumumab, a human anti-CD20 monoclonal antibody, in patients with relapsed/progressive diffuse large B-cell lymphoma (DLBCL) who were ineligible for autologous stem cell transplantation (TI) or who had relapse/progression after transplantation (PT). Eighty-one patients received ofatumumab 300 mg intravenously (IV) on Day 1, followed by seven weekly IV infusions of 1000 mg. Patients in the TI and PT groups had received a median of 3 (range, 1-7) and 5 (range, 2-7) prior therapies, respectively. One-third of patients did not respond to the last prior therapy, and 53% had failed two or more rituximab-containing therapies. Overall response rate was 13% for the TI group (seven partial responses) and 8% for the PT group (two complete responses). Median progression-free survival was 2·6 months, and median duration of response was 9·5 months. The most common Grade 3-4 adverse events were neutropenia (11%), leucopenia (6%), lymphopenia (6%) and thrombocytopenia (6%). Sixteen deaths have been reported, with disease progression as the most common cause of death. In conclusion, ofatumumab monotherapy was well tolerated and provided clinical benefit to some DLBCL patients in this study.