GlaxoSmithKline (GSK) and Genmab have reported positive results from a Phase III study of Arzerra (ofatumumab) combined with chlorambucil in previously-untreated chronic lymphocytic leukaemia (CLL) patients.
Designed to target an epitope on the CD20 molecule, the human monoclonal antibody ofatumumab is indicated for the treatment of CLL in patients who failed to respond to fludarabine and alemtuzumab.
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GlaxoSmithKline biopharmaceutical development vice president Dr Kathy Rouan said; "As the aim of treating CLL, particularly in the frontline setting, is to maximise progression free survival while minimising side effects, we are therefore encouraged by these promising results."
The study, which compared treatment with the combination therapy to chlorambucil alone, met its primary endpoint of progression free survival (PFS), with a total of 447 patients enrolled.
Patients randomised with the combination therapy demonstrated a 9.3 month improvement in the time lived without worsening of their disease compared to those randomised with chlorambucil alone.
The study reported no unexpected safety findings, however the most common serious adverse events observed within 60 days of previous treatment include neutropenia, anaemia, pneumonia and pyrexia.
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By GlobalDataGenmab chief executive officer Dr Jan van de Winkel said ofatumumab plus chlorambucil may become an additional treatment option for the care of patients with CLL.
"We look forward to submitting the study results, including secondary endpoints, to the International Workshop on CLL (iwCLL) in Cologne, Germany this September," van de Winkel said.
With the achievement of positive results, regulatory submissions in the EU, US and other regions are expected shortly.
Image: Peripheral blood smear showing CLL cells. Photo: Courtesy of Mary Ann Thompson.
