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?s lymphoma (iNHL). The study compared the efficacy and safety of obinutuzumab (Gazyva?; Genentech) plus chemotherapy (CHOP, CVP or bendamustine) followed by obinutuzumab alone, head-to-head with rituximab (Rituxan?; Genentech) plus chemotherapy followed by rituximab alone.
Follicular lymphoma is the most common indolent (slow-growing) form of non-Hodgkin?s lymphoma (NHL), accounting for about one in five cases of NHL. It is considered incurable and relapse is common. In the United States, it is estimated that more than 14,000 new cases of follicular lymphoma will be diagnosed in 2016.
Results from a pre-planned interim analysis showed that obinutuzumab-based treatment significantly reduced the risk of disease worsening or death (progression-free survival; PFS, as assessed by investigator) compared to Rituxan-based treatment.
Adverse events with either obinutuzumab or rituximab 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,” noted Sandra Horning, M.D., chief medical officer and head of Global Product Development at Genetech.
“GALLIUM is the second study in which Gazyva showed superior progression-free survival compared to rituximab, when each was combined with chemotherapy,” she added.
In the first head-to-head comparison of obinutuzumab and rituximab, the CLL11 study in people with previously untreated chronic lymphocytic leukemia, obinutuzumab plus chlorambucil significantly extended PFS compared to treatment with rituximab plus chlorambucil (median PFS 26.7 months vs. 14.9 months, respectively; HR=0.42; 95% CI, 0.33-0.54; p<0.0001).
Common side effects
The most common side effects of Gazyva plus chlorambucil were infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea and diarrhea.
The GALLIUM-study (NCT01332968) is a global Phase III open-label, multicenter, randomized two-arm study examining the efficacy and safety of obinutuzumab plus chemotherapy, as compared to rituximab plus chemotherapy, followed by obinutuzumab or Rituxan alone for up to two years.
Chemotherapies used were CHOP, CVP or bendamustine as selected by each participating study site.
The GALLIUM-study included 1,401 patients with previously untreated indolent non-Hodgkin?s lymphoma (iNHL), of which 1,202 patients had follicular lymphoma. The primary endpoint of the study was investigator-assessed progression-free survival (PFS) in patients with follicular lymphoma, with secondary endpoints including PFS assessed by independent review committee (IRC), PFS in the overall study population (iNHL), response rate (overall response, ORR; and complete response, CR), overall survival (OS), disease-free survival (DFS) and safety.
The GALLIUM study is being conducted in cooperation with the German Low Grade Lymphoma Study Group (GLSG; Germany), the East German Study Group Hematology and Oncology (OSHO; Germany) and the National Cancer Research Institute (NCRI; United Kingdom).
Engineered monoclonal antibody
Obinutuzumab is an engineered monoclonal antibody designed to attach to CD20, a protein found on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body’s immune system. Obinutuzumab was discovered by Roche Glycart AG, a wholly owned, independent research unit of Roche. In the United States, Gazyva is part of a collaboration between Genentech and Biogen. Obinutuzumab is being studied in a large clinical program, including the Phase III GOYA study comparing obinutuzumab plus CHOP chemotherapy head-to-head with Rituxan plus CHOP chemotherapy in first-line diffuse large B-cell lymphoma (DLBCL).
Additional combination studies investigating obinutuzumab with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are planned or underway across a range of blood cancers.
Last editorial review: May 26, 2016.
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