GSK, Genmab announce positive results from Phase III study of Arzerra

Conducted on 447 patients with previously untreated CLL and evaluated by an independent review committee (IRC), the study met its primary endpoint of progression free survival (PFS).

Patients randomized to ofatumumab and chlorambucil showed a 9.3 month improvement without worsening of their disease (median PFS) compared to patients randomized to chlorambucilalone.

Within 60 days of last treatment, the investigator reported febrile neutropenia (5%), anaemia (4%), pneumonia (4%), and pyrexia (2%)as the most common serious adverse events.

About 3% of infusion reactions were of serious nature, while infusion reactions were reported mild to moderate in severity.

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."

"We are planning regulatory submissions in the EU, US, and other regions in the coming months."

CLL, which is a common form of leukaemia in adults, will account for over 15,680 new cases and more than 4,580 deaths in the US alone in 2013, according to a report by the American Cancer Society.