Obinutuzumab and lenalidomide — known as the GALEN regimen — appear to yield desirable clinical outcomes without a high degree of toxicity among patients with previously untreated with follicular lymphoma (FL), according to research published in Blood.
FL accounts for approximately one-third of diagnosed cases of indolent lymphomas. While rituximab-based regimens that include chemotherapy have improved outcomes in this patient population over the past several decades, the use of a chemotherapy-free rituximab and lenalidomide combination appeared, in previous study, to yield good survival outcomes, with fewer adverse events than those seen with regimens that include chemotherapy.
Previous research suggests that obinutuzumab, a type 2 anti-CD20 monoclonal antibody, may improve antibody-dependent cellular toxicity compared with rituximab, and showed promising efficacy results when combined with chemotherapy in the FL setting. For this phase 2 study (ClinicalTrials.gov Identifier: NCT01582776), researchers evaluated the safety and efficacy of the GALEN regimen among previously untreated patients with FL.
Patients received the drug combination for 6 months; this was followed by 1 year of combination maintenance and 1 year of obinutuzumab-only maintenance. The study’s primary endpoint was complete response rate.
Overall, 100 patients were enrolled and treated on this study, while 73 completed the full maintenance regimen per the study protocol. At baseline, the median age was 60.5 years (range, 32-89), 55% of patients were female sex, 67% of patients had Ann Arbor stage IV disease, and 48% of patients had bone marrow involvement.
After induction, the complete response rate was 47% and the overall response rate was 92%. Post-hoc analysis, which included patients without bone marrow assessment, suggested, however, that the complete metabolic response rate was 80%.
The median follow-up was 3.7 years, at which point the 3-year progression-free and overall survival rates were 82% and 94%, respectively.
The most common grade 3 or worse adverse event was neutropenia (47%), with 2% of patients developing febrile neutropenia overall. No other grade 3 or worse adverse event was noted in more than 3% of patients.
“Results of the study showed that obinutuzumab and lenalidomide in combination for 6 months, followed by a first year of maintenance with both drugs and a second year of maintenance with obinutuzumab only, is active and safe in patients with previously untreated, high tumor burden FL,” the authors wrote.
Disclosure: The study author(s) declared affiliations with biotech, pharmaceutical, or device companies. Please see the original reference for a full list of authors’ disclosures.
Bachy E, Houot R, Feugier P, et al. Obinutuzumab plus lenalidomide in advanced, previously untreated follicular lymphoma in need of systemic therapy: a LYSA study. Blood. 2022;139(15):2338-2346. doi:10.1182/blood.2021013526