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GSK and Genmab's Arzerra fails lymphoma trial

Cancer drug unable to beat Roche's MabThera in late-stage study

GlaxoSmithKline GSKThere was disappointment for GlaxoSmithKline and Genmab yesterday after it was revealed that their Arzerra failed a late-stage trial in a form of lymphoma and would likely be dropped from development in that indication.

Moreover, there were signs that Arzerra (ofatumumab) was more likely to cause infusion reactions and raise serum creatinine levels - possible sign of liver toxicity - than Roche's Rituxan/MabThera (rituximab), the comparator drug in the trial.

The ORCHARRD study compared Arzerra to MabThera - given on top of chemotherapy - in patients suffering from relapsed or refractory diffuse large B-cell lymphoma (DLBCL). There was no difference between the two anti-CD20 drugs in terms of progression-free survival, the primary outcome measure, and they were also comparable in terms of serious side effects.

GSK and Genmab have struggled to make headway in the market against their entrenched rival, which remains Roche's top product with sales of more than $7bn a year and was ranked at number six in the top 25 pharmaceutical products of 2013.

Arzerra is already sold to treat chronic lymphocytic leukaemia (CLL) in patients who are refractory to Genzyme's Campath (alemtuzumab) and Fludara (fludarabine) drugs, and recently had its uses extended to include combination use with GSK's Leukeran (chlorambucil) as a first-line regimen in patients for whom fludarabine is not advised.

Sales of Arzerra were a little under $100m last year - albeit up strongly on the prior year - but GSK and Genmab need a steady stream of new indications if the drug is to make any headway against MabThera.

Meanwhile, other rivals are reaching the market, such as Johnson & Johnson/Pharmacyclics' small-molecule drug Imbruvica (ibrutinib) which was approved in the US in November 2013 as a second line treatment for patients with mantle cell lymphoma.

Imbruvica has also been filed for use in CLL, outperforming Arzerra in this indication in a recent study, while GSK and Genmab's drug could also see competition from Gilead Sciences with its PI3K inhibitor idelalisib, which was superior to MabThera in a CLL trial reported last year.

"We are disappointed that the ORCHARRD study did not meet its primary endpoint," said Rafael Amado, head of oncology R&D at GSK, adding: "we will further analyse these results to better understand the findings."

Meanwhile, Arzerra remains in phase III testing for follicular lymphoma (FL), and is in earlier-stage trials for Waldenstrom's macroglobulinemia (WM) and relapsing-remitting multiple sclerosis (RRMS).

Article by
Phil Taylor

21st May 2014

From: Research



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