Rituximab plus lenalidomide as a potential firstline option

<p class="article-intro">RELEVANCE is the first clinical trial comparing lenalidomide plus rituximab versus standard chemoimmunotherapy followed by rituximab maintenance in untreated FL patients. </p> <hr /> <p class="article-content"><p>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 (R²).</p> <p>RELEVANCE is the first randomized phase III superiority comparison of the immunomodulatory regimen R² versus 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.</p> <p>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 versus R-chemo groups (48 % vs. 53 % ), and 3-year PFS rates were 77 % versus 78 % . The 3-year overall survival rates were high for both arms at 94 % .</p> <p>The safety profiles for R² versus 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.</p> <p>In summary, RELEVANCE is the first randomized phase-III-trial comparing R² versus 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.</p> <p><strong>Reference:</strong> <br /> <em>Morschhauser F et al.: RELEVANCE: phase III efficacy and safety study of lenalidomide plus rituximab (R2) versus rituximab plus chemotherapy, followed by rituximab, in previously untreated follicular lymphoma. EHA Annual Congress, abstract # S154</em></p></p>