Roche’s phase III study of Gazyva meets primary endpoint early

Gazyva/Gazyvaro is an engineered monoclonal antibody designed to attach to CD20, a protein found on several B cells, but not on stem cells or plasma cells.

It is believed to work by attacking and destroying targeted cells both directly and together with the body’s immune system.

Gazyva/Gazyvaro is currently approved in over 70 countries in combination with chlorambucil, for people with previously untreated chronic lymphocytic leukaemia.

Results from an interim analysis showed that the Gazyva/Gazyvaro-based treatment significantly reduced the risk of the disease worsening or death compared to the MabThera/Rituxan-based treatment.

Adverse events with either treatments were consistent with what was demonstrated in earlier clinical trials when each was combined with several chemotherapies.

Infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea, and diarrhoea were the most common side effects of Gazyva/Gazyvaro and chlorambucil.

Gazyva was discovered by Roche Glycart. In the US, Gazyva is part of a collaboration between Roche’s subsidiary Genentech and Biogen.

Genentech chief medical officer and head of global product development Sandra Horning said: "People with follicular lymphoma continue to need better initial treatment options because their disease is incurable and becomes more difficult to treat with each relapse.

" Gallium is the second study in which Gazyva/Gazyvaro showed superior progression-free survival compared to MabThera/Rituxan, when each was combined with chemotherapy."

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