New data published in the New England Journal of Medicine
concludes that in the Phase III GALLIUM Study, a more successful rate of progression-free survival (PFS) was seen in follicular lymphoma patients when treated with obinutuzumab-based immunochemotherapy and maintenance therapy as opposed to Rituxan, a rituximab-based therapy.
GALLIUM is the first Phase III study in follicular lymphoma to show superior PFS over Rituxan, which was approved in June and is the current standard of care.
Follicular lymphoma, the most commonly-occurring indolent type of non-Hodgkin lymphoma, progresses slowly and is characterized by cycles of remission and relapse. It originates in the B lymphocytes, or B cells, and frequent symptoms include the swelling of lymph nodes in the neck, underarms, abdomen, or groin. Patients have reported incidents of flu-like symptoms, like night sweats, as well.
Robert Marcus, M.B. of Kings College led a team of researchers on the GALLIUM study, and compared obinutuzumab, a glycoengineered type II anti-CD20 monoclonal antibody to rituximab-based therapy. A total of 1202 patients with follicular lymphoma were randomly assigned to undergo induction treatment with either of the 2 chemotherapy types (601 patients in each group). Patients with a response received maintenance treatment for up to 2 years with the antibody that they had received in induction, with the primary endpoint being investigator-assessed PFS.
A planned interim analysis was utilized after a median follow-up of 34.5 months, and demonstrated that obintuzumab-based chemotherapy resulted in a significantly lower risk of progression, relapse, or death than rituximab-based chemotherapy; in an estimated 3-year rate of progression-free survival, the results showed 80.0% vs. 73.3% in favor of the former.
Similar response rates were displayed among the 2 groups, and while adverse events (AEs) and serious AEs were more frequent in the obinutuzumab group, the rate of AEs resulting in death were similar in both studies. The most frequent AEs were infusion-related, although nausea and neutropenia were both common.
Marcus R, Davies A, Ando K, et al. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. New England Journal of Medicine
. 2017;377:1331-1344. doi: 10.1056/NEJMoa1614598