Genmab pulls plug on Phase III Arzerra trial
pharmafile | November 24, 2015 | News story | Manufacturing and Production, Research and Development |  Arzerra, Genmab, non-Hodgkin's lymphoma, non-Hodgkin’s lymphoma, ofatumumab, phase III, phase III failureÂ
Genmab has stopped a Phase III study of its CD20-directed monoclonal antibody Arzerra, after it was shown to be unlikely to show superiority to Roche’s MabThera as a treatment of relapsed follicular non-Hodgkin’s lymphoma (NHL).
The 516-patient study aimed to prove superiority of Arzerra (ofatumumab) over MabThera (rituximab) in people with NHL that has relapsed at least six months after completion of treatment. But following interim analysis performed by an Independent Data Monitoring Committee, Genmab realised it was not worth the expense of continuing the trial.
“The outcome of the interim analysis in this study is disappointing as we had hoped to see superiority of ofatumumab. The data from the study will now be prepared so that it can be presented at a future scientific conference,” says Jan van de Winkel, chief executive of Genmab.
Genmab insist that the failure of this trial would not impact on any other ongoing studies with Arzerra and that no new safety concerns were identified in the trial. The drug is being developed under a co-development and collaboration agreement between Genmab and GSK. The compound is approved in more than 50 countries worldwide for the treatment of patients with chronic lymphocytic leukaemia (CLL) who are refractory after prior treatment with fludarabine and alemtuzumab.
The UK healthcare watchdog NICE approved the drug last year for this indication on the NHS, following a price cut, after rejecting it four years earlier.
Follicular lymphoma is a slow-growing cancer of the B-cells, accounting for about 20% of non-Hodgkin’s lymphomas (NHL). Ofatumumab targets the CD20 molecule found on the surface of CLL cells and normal B lymphocytes, directing the body’s immune system to fight cancerous B-cells.
Joel Levy.
Related Content
Genmab to submit FDA application for lymphoma therapy
Global biotechnology company Genmab plans to submit a supplemental Biologics License Application (sBLA) to the …
Biogen Phase III choroideremia study did not meet primary endpoint
Biogen has announced that its investigational gene therapy study for the potential treatment of choroideremia …
Experimental COVID antibody treatment successful in trials
Celltrion has announced positive top-line data for its experimental antibody COVID-19 treatment, with Phase III …
