BioCentury
ARTICLE | Clinical News

Arzerra ofatumumab: Phase II data

May 6, 2013 7:00 AM UTC

Top-line data from an open-label, international Phase II trial in 97 patients showed that IV ofatumumab plus IV bendamustine led to an ORR of 95% in patients with previously untreated CLL (n=44) and 74% in patients with relapsed CLL (n=53). Additionally, complete response rates were 43% in previously untreated patients and 11% in relapsed patients. The combination was well tolerated with neutropenia, nausea, rash, pyrexia and thrombocytopenia reported as the most common adverse events. All patients received 3 cycles of ofatumumab plus bendamustine and were eligible for a maximum of 6 cycles dependent upon treatment response. Genmab said data from 5 pivotal trials of ofatumumab are expected over the next 15 months, including data from a Phase III trial of ofatumumab as first-line treatment of CLL which are expected this half. ...