Date: 2011-08-05
Type of information:
phase: 2
Announcement: results
Company: Genmab (Denmark)
Product: ofatumumab
Action mechanism: Ofatumumab is a human monoclonal antibody which targets an epitope in the CD20 molecule encompassing parts of the small and large extracellular loops,
Disease: diffuse large B-cell lymphoma
Therapeutic area: Cancer Oncology
Country:
Trial details: Patients in the study had previously received first line treatment with rituximab combined with standard chemotherapy. Patients received three cycles of ofatumumab in combination with ICE or DHAP salvage chemotherapy, which is used when cancer recurs or does not respond to first line treatment. The primary objective of the study was to evaluate the overall response rate of patients to ofatumumab in combination with ICE or DHAP chemotherapy according to criteria recognized by regulatory authorities known as the Revised Response Criteria for Malignant Lymphoma.
Latest
news: Genmab has announced top-line results from a Phase II study of ofatumumab in combination with salvage chemotherapy to treat relapsed or refractory aggressive lymphoma, including Diffuse Large B-Cell Lymphoma (DLBCL).
A total of 61 patients with aggressive lymphoma, who had persistent or progressive disease after first-line treatment with rituximab combined with chemotherapy, were treated in the study. The overall response rate (ORR) was 61%. There were no unexpected safety findings. The most common grade 3 or higher adverse events were thrombocytopenia (59% of pts), anemia (36%), neutropenia (26%), lymphopenia (23%), leukopenia (18%), febrile neutropenia (13%) and hypokalemia (13%).
These data will be submitted for presentation at the 2011 Annual Meeting of the American Society of Hematology (ASH) in San Diego, US this December.
