Lenalidomide Plus Rituximab for Previously Untreated Advanced Follicular Lymphoma: The 10-Year RELEVANCE Trial Analysis

Lenalidomide Plus Rituximab for Previously Untreated Advanced Follicular Lymphoma: The 10-Year RELEVANCE Trial Analysis Authors: Nicolas Gower, MD; Pierre Feugier, MD; Jason Westin, MD; Jean-Marc Schiano De Colella, MD; Hervé Tilly, MD; M. Lia Palomba, MD; Edith Julia, MD; Gandhi-Laurent Damaj, MD, PhD; Amandine Durand, MD; Ian Flinn, MD; François Lemonnier, MD, PhD; Nadine Morineau, MD; Loic Ysebaert, MD, PhD; Nancy Bartlett, MD; Catherine Thieblemont, MD; Vincent Ribrag, MD; Thomas Gastinne, MD; Arthur Dony, MD; Ludovic Fouillet, MD; Stephanie Guidez, MD; Roch Houot, MD, PhD; Maria Gomes Da Silva, MD; Jeffrey Barnes, MD, PhD; Fontanet Bijou, MD; Guillaume Cartron, MD, PhD; Alejandro Martin Garcia-Sancho, MD, PhD; Herbert Eradat, MD; Morgane Cheminant, MD, PhD; Armando Lopez Guillermo, MD; Pau Abrisqueta, MD; Julie Abraham, MD; Clémentine Sarkozy, MD, PhD; Koji Izutsu, MD; Gilles Crochet, MD; Laurie H. Sehn, MD, MPH; Argyrios Gkasiamis, MD; Marie Laurence Yge; Loic Chartier; Nathan Fowler; Luc Xerri, MD; Gilles Salles, MD; Franck Morschhauser, MD, PhD https://www.medscape.org/viewarticle/lenalidomide-plus-rituximab-advanced-follicular-lymphoma-2026a1000jid?page=1&src=wnl_tpal_260619_mscpedu&uac=148436CN&impID=8438174 In the multinational, phase 3 RELEVANCE trial, 1030 patients with previously untreated follicular lymphoma were randomized to receive rituximab + lenalidomide (R2; n = 513) or rituximab-based immunochemotherapy (R-Chemo; n = 517). In the final analysis, at 120 months of follow-up, median progression-free survival (PFS) was comparable between the treatment groups: 110.6 months with R2 vs 102.8 months with R-Chemo, according to the independent review committee assessment. The 10-year PFS rates were 46.4% for R2 and 46.6% for R-chemo. Median overall survival (OS) and time-to-next lymphoma treatment (TTNLT) were not reached in either arm; 10-year OS rates were 82.4% for R2 and 81.1% for R-chemo, and 10-year TTNLT rates were 62.2% for R2 and 66.3% for R-chemo. Overall, patients with progression of disease within 24 months (POD24) had a poorer prognosis than those without POD24 (hazard ratio, 6.215; P <.0001); however, no difference was observed between the study groups. The incidence of second primary malignancies (SPMs) was 2.11 cases per 100 patient-years (95% confidence interval, 1.80-2.46). Only 9 transformations occurred after 24 months (3 with R2 vs 6 with R-chemo). In each study group, 87 patients died, mainly because of lymphoma progression and SPMs. This long-term follow-up of RELEVANCE confirmed that R2 provides a chemotherapy-free alternative to immunochemotherapy in this patient population. This trial was registered at www.clinicaltrials.gov as NCT01476787 and NCT01650701 and at EudraCT as 2011-002792-42.