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Date: 2010-08-09
Phase: III
Anouncement: Result
Biotech: Genmab (Denmark)
Pharma: GSK (UK)
Product: Arzerra® (ofatumumab)
Disease: fludarabine and alemtuzumab refractory chronic lymphocytic leukemia
Other: GSK and Genmab announced topline results from the concluded pivotal trial of ofatumumab in patients with fludarabine and alemtuzumab refractory chronic lymphocytic leukemia (CLL).
Ofatumumab was given accelerated approval by the FDA on October 26, 2009 for the treatment of patients with CLL who are refractory to fludarabine and alemtuzumab treatment based on the interim results from this trial in 59 patients (See clinical_studies)

A total of 95 patients with fludarabine and alemtuzumab refractory CLL were treated in the study. The objective response rate, as determined by an Independent Review Committee, in the study was 51%. In addition to the 95 patients in the efficacy analysis the study also included 128 patients with relapsed or refractory CLL, who were not refractory to both fludarabine and alemtuzumab.

There were no unexpected safety findings reported with the total study population (n=223). The most common adverse reactions (≥10%) occurring in patients treated with Arzerra® were pyrexia (21%), anemia (18%), diarrhea (17%), neutropenia, fatigue (16%), dyspnea (15%), pneumonia (15%), chills (13%), rash (13%), nausea (13%), bronchitis (12%), peripheral edema (11%), back pain (10%) and upper respiratory tract infection (10%).

Results from this concluded pivotal trial are consistent with the efficacy and safety data reported in the interim analysis and demonstrate the activity of single-agent ofatumumab in patients with heavily pretreated fludarabine and alemtuzumab-refractory chronic lymphocytic leukemia.