The GALEN combination of obinutuzumab and lenalidomide was an active immunomodulatory combination with a controllable safety profile in different forms of lymphoma. For a study, researchers presented the effectiveness and safety findings from the phase 2 GALEN research, which included previously untreated patients with advanced follicular lymphoma (FL). Eligible 18-year-old patients had an Eastern Cooperative Oncology Group performance status 2 and a high tumor burden, grade 1 to 3a FL. For six 28-day cycles, obinutuzumab (1000 mg IV, days 8, 15, and 22, cycle 1; day 1, cycles 2-6) was combined with lenalidomide (20 mg/d, days 1-21, cycle 1; days 2-22, cycles 2-6). Obinutuzumab (1000 mg every 2 cycles) was combined with lenalidomide (10 mg, days 2-22) for 12 cycles (year 1), followed by obinutuzumab (1000 mg every 56 days) for 6 cycles (year 2). According to the 1999 International Working Group criteria, the major end goal was the complete response rate (CRR) following induction. A total of 100 patients were enrolled between October 2015 and February 2017.
The CRR after induction was 47%, while the overall response rate (ORR) was 92%. Post-hoc studies based on the 2014 Lugano classification, including patients with missing bone marrow tests, showed an additional 13 patients meeting CRR criteria, resulting in an 80% complete metabolic response and a 94% ORR. Three-year progression-free survival and overall survival were 82% and 94%, respectively, after a median follow-up of 3.7 years. Neutropenia was the most prevalent adverse event (48% any grade; 47% grade 3). Only 2% of individuals had febrile neutropenia; the rest were mostly grade 2. There was no other particular grade 3 toxicity that occurred at a frequency greater than 3%. Overall, the findings indicated that the chemotherapy-free GALEN backbone demonstrated promise clinical effectiveness in previously untreated patients with high tumor burden FL. Except for neutropenia, the combination has an excellent safety profile.
