Date: 2013-05-01
Type of information:
phase: 2
Announcement: results
Company: Genmab (Denmark)
Product: ofatumumab
Action mechanism: Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops. It is being developed under a co-development and commercialization agreement between Genmab and GSK. Ofatumumab is marketed under the trade name Arzerra® and is approved to treat chronic lymphocytic leukemia (CLL) in patients who are refractory to fludarabine and alemtuzumab in the US and EU as well as other territories.
Disease: relapsed or previously untreated chronic lymphocytic leukemia
Therapeutic area: Cancer - Oncology
Country:
Trial details: This Phase II study included patients who had untreated and relapsed CLL. Patients in the study were treated with a maximum of 6 cycles of study treatment. All subjects received 3 cycles of ofatumumab plus bendamustine and were eligible for additional treatment cycles dependent upon response to treatment. The primary objective of the study was to evaluate the investigator-assessed overall response rate according to the International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCIWG) guidelines, in two populations: subjects with untreated CLL and subjects with relapsed CLL treated with ofatumumab plus bendamustine.
Latest
news: * On May 1, 2013, Genmab has announced top-line results from a Phase II study of ofatumumab in combination with bendamustine in patients with untreated or relapsed chronic lymphocytic leukemia (CLL).A total of 97 patients were treated in the study and 87% of patients completed the full course of six cycles of therapy. The study population comprised 44 patients with untreated CLL and 53 patients with relapsed CLL. In patients with untreated CLL the overall response rate (ORR) was 95%, with a complete response (CR) rate of 43%. The ORR in patients with relapsed CLL was 74%, with a CR rate of 11%. Treatment with ofatumumab and bendamustine was well tolerated by patients in the study . The most common adverse reactions (>20% of patients) were neutropenia, nausea, rash, pyrexia and thrombocytopenia.This is the first set of key data Genmab expects to report for ofatumumab over the next 15 months. Data from five pivotal studies are due during this time period, including results from a Phase III study of ofatumumab in front line CLL during the first half of 2013,
