ASCO 2018 | Phase III RELEVANCE study compares R2 to R-Chemo

On Sunday 3^rd June an oral abstract session took place at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting. Abstract 7500 was presented by Nathan Fowler, The University of Texas MD Anderson Cancer Center, Texas, on the RELEVANCE study.

The randomized, phase III study looked at the combination of lenalidomide plus rituximab (R²) compared with chemotherapy with rituximab (R-chemo) followed by rituximab maintenance in patients with previously untreated follicular lymphoma (FL).

In the first 6 months, patients were treated with either 20mg per day (Day2-22/28) and rituximab 375 mg/m² or investigator/patient choice chemotherapy (R-CHOP 72%, R-B 23% and R-CVP 5%). Both treatment arms would then continue on to rituximab maintenance after 6 months up to a year. The co-primary endpoint was complete remission (CR) or CRu at 120 weeks.

Key Highlights

• 1,030 patients were enrolled in the study with 513 receiving R² and 517 receiving R-chemo
• The CRu was not statistically different at 120 weeks with R² vs R-chemo (59% vs 67%)
• Best overall response rate of R² vs R-chemo was 84% vs 89%
• Three-year independent review committee (IRC) duration of response for R² vs R-chemo was 77% vs 74%
• The IRC interim progression-free survival (PFS) was 77% for R² and 78% for R-chemo at a median follow-up of 37.9 months
• The 3-year overall survival (OS) was 94% for both treatment arms
• Safety data showed that there was more Grade 3/4 neutropenia in the R-chemo treatment arm (50%) compared with R² (32%)

Dr Fowler concluded his talk stating that the R² regimen was not superior to R-chemo based on the interim PFS analysis at 120 weeks and that the efficacy results were similar. The study is ongoing for continued follow-up of mature PFS and OS results.