When combined with chemotherapy, obinutuzumab was superior to rituximab with respect to progression-free survival in patients with previously untreated follicular lymphoma, preliminary data from the phase 3 GALLIUM trial has shown.1
For the multicenter, open-label study, researchers enrolled 1401 patients with previously untreated indolent non-Hodgkin lymphoma, of which 1202 patients had follicular lymphoma. Participants were randomly assigned to receive chemotherapy (CHOP, CVP, or bendamustine) with obinutuzumab followed by obinutuzumab alone, or chemotherapy plus rituximab followed by rituximab alone.
Results from a preplanned interim analysis show that obinutuzumab-based treatment significantly improve progression-free survival in contrast with rituximab-based treatment. Safety profiles were consistent with previous studies.
“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,” said Sandra Horning, MD, chief medical officer and head of Global Product Development for Genentech. “GALLIUM is the second study in which [obinutuzumab] showed superior progression-free survival compared to [rituximab], when each was combined with chemotherapy.”
In the first head-to-head trial between obinutuzumab and rituximab, patients with previously untreated chronic lymphocytic leukemia (CLL) experienced a longer progression-free survival with obinutuzumab plus chlorambucil compared with rituximab plus chlorambucil.
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In addition to being approved for the treatment of patients with previously untreated CLL, obinutuzumab is indicated for the treatment of relapsed/refractory follicular lymphoma, in combination with bendamustine, after a rituximab-containing regimen.
- Genentech’s Gazyva showed superior progression-free survival compared to Rituxan in people with previously untreated follicular lymphoma. Genentech. http://www.gene.com/media/press-releases/14628/2016-05-26/genentechs-gazyva-showed-superior-progre. Published May 26, 2016. Accessed May 27, 2016.