95% overall response rate and 43% complete response rate in patients with previously untreated chronic lymphocytic leukemia
74% overall response rate and 11% complete response rate in relapsed chronic lymphocytic leukemia
Treatment was well tolerated with 87% of patients completing the full treatment course
"These data show encouraging clinical responses in patients treated with ofatumumab, ARZERRA plus bendamustine, a commonly used chemotherapeutic agent, in both untreated and relapsed CLL. This is only the first set of key data we expect 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," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
ARZERRA is not approved for the treatment of untreated CLL anywhere in the world.
It is approved for use in fludarabine refractory CLL, in the US and EU