Genmab reports top-line results from Phase II CLL study of ofatumumab

1st May 2013 (Last Updated May 1st, 2013 18:30)

Genmab has reported top-line results from a Phase II study of ofatumumab combined with bendamustine in untreated and relapsed chronic lymphocytic leukemia (CLL).

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Genmab has reported top-line results from a Phase II study of ofatumumab combined with bendamustine in untreated and relapsed chronic lymphocytic leukemia (CLL).

In the study, which included 44 patients with untreated CLL and 53 patients with relapsed CLL, 87% of patients completed the full treatment course of six cycles.

A 95% overall response rate and 43% complete response rate was noted in patients with previously untreated CLL, while a 74% overall response rate and 11% complete response rate was noted in relapsed CLL.

Genmab chief executive officer Dr Jan van de Winkel said the data highlights encouraging clinical responses in patients treated with ofatumumab along with bendamustine 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," Jan van de Winkel said.

"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."

Ofatumumab and bendamustine treatment was well-tolerated by patients in the study, while the most commonly reported adverse reactions included neutropenia, nausea, rash, pyrexia and thrombocytopenia.

The investigator-assessed overall response rate was the primary objective of the study.


Image: High-power magnification (1000X) of a Wright's stained peripheral blood smear showing chronic lymphocytic leukemia (CLL). Photo: Courtesy of Mary Ann Thompson.