European Hematology Association: Is RELEVANCE Relevant? Results of the Phase III Study of R2 vs R-chemo in First-line Follicular Lymphoma

- Chemoimmunotherapy (R-chemo) induction followed by rituximab maintenance is the standard of care in previously untreated, symptomatic follicular lymphoma (FL). Lenalidomide is an immunomodulatory agent with complementary mechanisms when combined with rituximab (ie, R2). RELEVANCE is the first randomized phase III superiority comparison of the immunomodulatory regimen R2 vs standard R-chemo, followed by rituximab maintenance, in previously untreated patients with advanced FL requiring treatment. There were 1030 patients randomized 1:1 who received treatment for a total duration of 120 weeks. The study had 2 co-primary endpoints of complete response (CR/CRu) at 120 weeks and progression-free survival (PFS; first interim analysis at 50% of events). Both groups had similar baseline characteristics. Superiority for R2 over R-chemo was not established for either co-primary endpoint. At a median follow-up of 37.9 months, CR/CRu at 120 weeks was similar in the respective R2 vs R-chemo groups (48% vs 53%), and 3-year PFS rates were 77% vs 78%. The 3-year overall survival rates were high for both arms at 94%. The safety profiles for R2 vs R-chemo were different. Higher grade 3/4 neutropenia (34% vs 50%) and febrile neutropenia (2% vs 6%) were associated with R-chemo, and higher grade 3/4 cutaneous reactions (7% vs 1%) were associated with R2. Second primary malignancies were reported in 7% of R2 patients and 9% of R-chemo patients and grade 5 adverse events were 1% in both arms. In summary, RELEVANCE is the first randomized phase III trial comparing R2 vs standard R-chemo, followed by rituximab maintenance, in previously untreated patients with FL. R2 and R-chemo showed similar efficacy with a different safety profile. These results show that R2, a novel immunomodulatory approach, is a potential first-line option for FL patients requiring treatment.      (Logo: http://mma.prnewswire.com/media/622259/EHA_Logo.jpg ) Presenter:  Dr Frank Morschhauser Affiliation:  Centre Hospitalier Universitaire Régional de Lille, Unité GRITA, Lille, France Topic:  RELEVANCE: PHASE III EFFICACY AND SAFETY STUDY OF LENALIDOMIDE PLUS RITUXIMAB (R2) VERSUS RITUXIMAB PLUS CHEMOTHERAPY, FOLLOWED BY RITUXIMAB, IN PREVIOUSLY UNTREATED FOLLICULAR LYMPHOMA Abstract S154 will be presented by Frank Morschhauser on Friday, June 15, 17:00-17:15 in Room A1. Embargo Please note that our embargo policy applies to all selected abstracts in the Press Briefings. For more information check our Congress Media Guidelines here. www.ehaweb.org