Obinutuzumab may improve survival and lower the risk of worsening disease compared with rituximab in patients with follicular lymphoma, according to results from the phase 3 GALLIUM study.
A total of 1401 patients with previously untreated, indolent non-Hodgkin lymphoma were enrolled in the study, 1202 of whom had follicular lymphoma, the most common form of slow-growing non-Hodgkin’s lymphoma. An estimated 14,000 new cases of follicular lymphoma will be diagnosed in 2016 and the disease is considered incurable.
All participants in the study were randomly assigned to receive either chemotherapy with obinutuzumab followed by obinutuzumab alone or chemotherapy plus rituximab followed by rituximab alone. The primary endpoint of the study was investigator-assessed progression-free survival (PFS) in patients with follicular lymphoma, with secondary endpoints of PFS assessed by independent review committee, PFS in the overall study population, response rate, overall survival, disease-free survival, and safety.
Results from a planned interim analysis revealed that PFS was significantly longer in the patients treated with obinutuzumab compared with those in the rituximab group. Adverse events associated with each treatment were consistent with what has been seen in previous clinical trials.
"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 at Genentech, the company that markets the drug. "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 comparison of the two medications, obinutuzumab plus chlorambucil significantly extended PFS compared with rituximab plus chlorambucil in patients with chronic lymphocytic leukemia (median PFS 26.7 months vs 14.9 months, respectively).
Investigators involved in the study are planning to present their findings at an unnamed medical meeting in the near future and will submit the results to the health authorities for approval consideration.