Roche’s lymphoma drug fails to beat rivals in Phase III trial
pharmafile | July 18, 2016 | News story | Research and Development, Sales and Marketing | Roche, lymphoma, phase III
Roche has announced that a Phase III trial evaluating Gazyva/Gazyvaro (obinutuzumab) in patients with previously untreated diffuse large B-cell lymphoma did not meet its primary endpoint of significantly improving progression-free survival compared to established treatment MabThera/Rituxan (rituximab).
Both administered alongside CHOP chemotherapy, no significant contrast in the reduction of the risk of disease worsening or death was observed between the two treatment arms in the late-stage trial.
The treatment combo is aimed at treating diffuse large B-cell lymphoma, which is the most common subtype of non-Hodgkin lymphoma. It is an aggressive type of the disease which, while responsive to treatment, causes relapse in approximately 40% of patients.
While it could be considered a setback for Roche in this treatment indication, the treatment combination has been successful in numerous recent trials. Gazyva/Gazyvaro is currently approved in more than 70 countries in combination with chlorambucil for people with previously untreated chronic lymphocytic leukaemia.
Sandra Horning, chief medical officer at Roche, says: “Two previous studies showed Gazyva/Gazyvaro helped people with previously untreated follicular lymphoma or chronic lymphocytic leukaemia live longer without their disease worsening compared to MabThera/Rituxan, when each was combined with chemotherapy.
“We were hopeful we could show a similar result for people when diffuse large B-cell lymphoma and once again improve on the standard of care. We will continue to analyse the GOYA data to better understand the results, and to study other investigational treatments in this disease with the goal of further helping these patients.”
Sean Murray
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