GSK’s Arzerra fails in lymphoma
pharmafile | May 21, 2014 | News story | Research and Development, Sales and Marketing | Arzerra, GSK, Genmab, non-Hodgkin lymphoma
Researchers from GlaxoSmithKline and Genmab will be returning to the drawing board after blood cancer drug Arzerra failed in a late-stage study to have an effect in the most common form of non-Hodgkin lymphoma (NHL).
The Phase III ORCHARD study was examining Arzerra (ofatumumab) and chemotherapy versus Roche’s MabThera (rituximab), also with chemotherapy, to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The disease accounts for 30% of all NHL in the western world, but to the companies’ chagrin there was no statistically significant difference in progression-free survival (PFS) between the treatment arms – which meant it did not meet the primary endpoint.
“Based on [these] results we are unlikely to move forward with a regulatory filing,” admits Jan van de Winkel, Genmab’s chief executive.
The head-to-head trial was important to GSK and Genmab, which sees Roche as a key rival in this space – and while there were no differences in adverse events between the arms, there are other issues which need looking at.
Specifically, these were a greater number of dose interruptions and delays due to infusion reactions and increased serum creatinine in the Arzerra arm, and these ‘require further analysis’.
“We are disappointed that the ORCHARD study did not meet its primary endpoint,” says Rafael Amado, GSK’s head of oncology R&D. “We will further analyse these results to better understand the findings and how they add to our collective knowledge of this disease.”
The firms say they plan to submit detailed data at a medical conference later this year “which we hope will provide further clarity on today’s headline results”.
Arzerra, licensed by GSK three years ago in a $2.1 billion deal, has been granted a‘breakthrough therapy’ designation by the FDA as a first-line treatment for chronic lymphocytic leukaemia (CLL) – the most common form of leukaemia in adults, with 11,000 new cases in Europe and 15,600 in the US each year.
It is a competitive area: Napp’s CLL drug Levact (bendamustine) and MabThera itself – sold as Rituxan in the US – are not going to give up their own positions.
MabThera has a licence for CLL, as well as for rheumatoid arthritis and NHL, but is set to face generic competition soon, eroding its multibillion dollar sales.
Roche’s newer drug Gazyva has also been approved in the US to treat people with previously untreated CLL – the first drug with breakthrough therapy designation to be approved.
Adam Hill
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