OREANDA-NEWS. Roche today announced positive results from the pivotal phase III GALLIUM study in people with previously untreated follicular lymphoma, the most common type of indolent (slow-growing) non-Hodgkin lymphoma (iNHL). The study compared the efficacy and safety of Gazyva®/Gazyvaro® (obinutuzumab) plus chemotherapy (CHOP, CVP or bendamustine) followed by Gazyva/Gazyvaro alone, head-to-head with MabThera®/Rituxan® (rituximab) plus chemotherapy followed by MabThera/Rituxan alone. Results from a pre-planned interim analysis showed that Gazyva/Gazyvaro-based treatment significantly reduced the risk of disease worsening or death (progression-free survival; PFS, as assessed by investigator) compared to MabThera/Rituxan-based treatment. Adverse events with either Gazyva/Gazyvaro or MabThera/Rituxan were consistent with what was seen in previous clinical trials when each was combined with various chemotherapies. Data from the GALLIUM study will be presented at an upcoming medical meeting and submitted to health authorities for approval consideration.

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

In the first head-to-head comparison of Gazyva/Gazyvaro and MabThera/Rituxan, the CLL11 study in people with previously untreated chronic lymphocytic leukaemia and comorbidities, Gazyva/Gazyvaro plus chlorambucil significantly extended PFS compared to treatment with MabThera/Rituxan plus chlorambucil (median PFS 26.7 months vs. 14.9 months, respectively; HR=0.42; 95% CI, 0.33-0.54; p<0.0001).1 The most common side effects of Gazyva/Gazyvaro plus chlorambucil were infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea, and diarrhoea.