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GSK eyes first-line use for leukaemia drug Arzerra

Positive phase III trial results back regulatory filings for earlier use

GSK GlaxoSmithKline house

GlaxoSmithKline (GSK) has said it will file for approval of its chronic lymphocytic leukaemia (CLL) therapy Arzerra as a first-line therapy on the back of positive phase III trial results.

The pharma company said that Arzerra (ofatumumab) given in combination with chlorambucil met its primary objective of improving progression-free survival (PFS) in the 447-patient study, setting up regulatory filings in "the EU, US, and other regions in the coming months".

Arzerra - an anti-CD20 antibody originally developed by Denmark's Genmab - has been available since 2009 for CLL patients whose disease is refractory to fludarabine and alemtuzumab.

However, the product has been slow to gain traction in the CLL market, mainly because it has been reserved for use as a second-line therapy and has found it hard to displace Roche's Rituxan/MabThera (rituximab) as the dominant therapy in the anti-CD20 category.

GSK reported that sales of the drug were just £60m in 2012, although first-quarter 2013 sales increased 65 per cent to £20.5m and additional growth is expected this year thanks to approval of the drug in Japan in March.

The latest data suggest there may be some additional upside for Arzerra in first-line CLL, with patients on the combination regimen achieving PFS of more than 22 months, compared to 13 months on chlorambucil alone. Side effects were as expected and manageable, said GSK.

"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," said Dr Kathy Rouan, GSK's vice president biopharmaceutical development.

Despite the latest positive results, Arzerra is unlikely to meet its early sales predictions - which had been as high as $800m a year when GSK licensed the drug from Genmab in 2006 - because the drug has been unable to show robust efficacy in trials of non-Hodgkin's lymphoma (NHL), a much larger indication for anti-CD20 drugs.

It remains in testing for other indications however, including follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Waldenstrom's macroglobulinemia (WM) and relapsing-remitting multiple sclerosis (RRMS).

31st May 2013

From: Research, Sales

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