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Genmab A/S
and GlaxoSmithKline plc
GSK announced today that their
Phase III study of ARZERRA^(R) (ofatumumab) in combination with chlorambucil
versus chlorambucil alone in patients with previously untreated chronic
lymphocytic leukemia (CLL) met its primary endpoint of progression free
survival (PFS) as assessed by an Independent Review Committee (IRC).
A total of 447 patients were enrolled in the study. A 9.3 month improvement in
the time a patient lived without worsening of their disease (median PFS) was
seen in patients randomized to ofatumumab and chlorambucil compared to
patients randomized to chlorambucil alone (22.4 months vs. 13.1 months; Hazard
Ratio 0.57; p<0.001).
There were no unexpected safety findings. The most common (>=1%) serious
adverse events as reported by the investigator within 60 days of last
treatment were neutropenia [including febrile neutropenia] (5%), anaemia (4%),
pneumonia (4%), and pyrexia (2%). Infusion reactions were mild to moderate in
severity with 3% of infusion reactions reported as serious.
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