Lenalidomide plus rituximab for previously untreated advanced follicular lymphoma: the 10-year RELEVANCE trial analysis

In the multinational, phase 3 RELEVANCE trial, 1,030 patients with previously untreated follicular lymphoma were randomized to receive rituximab plus lenalidomide (R2; n=513) or rituximab-based immunochemotherapy (R-Chemo; n=517). In the final analysis, at 120 months of follow-up, median PFS was comparable between the treatment groups: 110.6 months with R2 versus 102.8 months with R-Chemo, according to Independent Review Committee assessment. The 10-year PFS rates were 46.4% and 46.6%, respectively. Median overall survival (OS) and time-to-next lymphoma treatment (TTNLT) were not reached in either arm; 10-year OS rates were 82.4% and 81.1%, respectively, and 10-year TTNLT rates were 62.2% and 66.3%, respectively. Overall, patients with POD24 had a poorer prognosis compared to those without POD24 (HR, 6.215; P<0.0001); 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% CI, 1.80-2.46). Only 9 transformations occurred after 24 months (3 with R2 versus 6 with R-chemo). In each study group, 87 patients died, mainly due to lymphoma progression and SPMs. This long-term follow-up of RELEVANCE confirmed that R2 provides a chemo-free alternative to immunochemotherapy in this patient population. Trial registration: NCT01476787 and NCT01650701; EudraCT: 2011-002792-42.

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Journal
Blood
Published
2026-03-31
DOI
https://doi.org/10.1182/blood.2026033126
Primary Topic
Lymphoma Diagnosis and Treatment
Type
article
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article

Lenalidomide plus rituximab for previously untreated advanced follicular lymphoma: the 10-year RELEVANCE trial analysis

Ian W. Flinn, Nicolas Gower, L. Ysebaert, Morgane Cheminant et al.
Blood
Lymphoma Diagnosis and Treatment
article

Lenalidomide plus rituximab for previously untreated advanced follicular lymphoma: the 10-year RELEVANCE trial analysis

Ian W. Flinn, Nicolas Gower, L. Ysebaert, Morgane Cheminant, Koji Izutsu, Edith Julia, Clémentine Sarkozy, Nathan Fowler, Luc Xerri, Thomas Gastinne, Gilles Crochet, Fontanet Bijou, Herbert Aaron Eradat, J. Barnes, Nadine Morineau, Gilles Salles, Marie-Laurence Yge, Ludovic Fouillet, A López-Guillermo, MG Silva, F. Morschhauser, Jean-Marc Schiano Schiano de Colella, Pau Abrisqueta, Pierre Feugier, Catherine Thieblemont, Nancy Bartlett, Vincent Ribrag, Jason R Westin, Amandine Durand, M. Lia Palomba, François Lemonnier, Loic Chartier, Julie Abraham, Alejandro Martin Martin Garcia-Sancho, Stephanie Guidez, Roch Houot, Laurie H Sehn, Guillaume Cartron, Hervé Tilly, Dony Arthur, Argyrios Gkasiamis
article en

Abstract

In the multinational, phase 3 RELEVANCE trial, 1,030 patients with previously untreated follicular lymphoma were randomized to receive rituximab plus lenalidomide (R2; n=513) or rituximab-based immunochemotherapy (R-Chemo; n=517). In the final analysis, at 120 months of follow-up, median PFS was comparable between the treatment groups: 110.6 months with R2 versus 102.8 months with R-Chemo, according to Independent Review Committee assessment. The 10-year PFS rates were 46.4% and 46.6%, respectively. Median overall survival (OS) and time-to-next lymphoma treatment (TTNLT) were not reached in either arm; 10-year OS rates were 82.4% and 81.1%, respectively, and 10-year TTNLT rates were 62.2% and 66.3%, respectively. Overall, patients with POD24 had a poorer prognosis compared to those without POD24 (HR, 6.215; P<0.0001); 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% CI, 1.80-2.46). Only 9 transformations occurred after 24 months (3 with R2 versus 6 with R-chemo). In each study group, 87 patients died, mainly due to lymphoma progression and SPMs. This long-term follow-up of RELEVANCE confirmed that R2 provides a chemo-free alternative to immunochemotherapy in this patient population. Trial registration: NCT01476787 and NCT01650701; EudraCT: 2011-002792-42.

Blood
Santa Monica College (US), Memorial Sloan Kettering Cancer Center (US), The University of Texas MD Anderson Cancer Center (US), Inserm (FR), Washington University in St. Louis (US), Institut National Polytechnique de Toulouse (FR), Prostate Cancer Foundation (US), Institut Gustave Roussy (FR), Centre Hospitalier Universitaire de Lille (FR), Massachusetts General Hospital (US), Centre Hospitalier Universitaire de Montpellier (FR), CHU Dinant Godinne UCL Namur (BE), Assistance Publique – Hôpitaux de Paris (FR), Bristol-Myers Squibb (France) (FR), Institut universitaire du cancer de Toulouse Oncopole (FR), Complejo Hospitalario de Salamanca (ES), Centre Hospitalier Régional et Universitaire de Nancy (FR), Hospices Civils de Lyon (FR), Saint John's Health Center (US), The Lymphoma Academic Research Organisation (FR), Roche (France) (FR), Centre Hospitalier Métropole Savoie (FR), Délégation Centre-Est (FR), Centre Hospitalier Universitaire de Poitiers (FR), Institute Cancer De La Loire Lucien Neuwirth (FR), Hôpital Lyon Sud (FR), Hospital Clínic de Barcelona (ES), CHU Dijon Bourgogne (FR), Centre Hospitalier Universitaire de Limoges (FR), Vall d'Hebron Hospital Universitari (ES), Institut Bergonié (FR), Tennessee Oncology (US), Hôpital Saint-Louis (FR), Centre Hospitalier Départemental Vendée (FR), Institut Paoli-Calmettes (FR), Centre Hospitalier Universitaire de Rennes (FR), Centre Hospitalier Universitaire de Saint-Étienne (FR), Toranomon Hospital (JP), Centre Henri Becquerel, Groupe de Recherche sur les formes Injectables et les Technologies Associées, Bristol-Myers Squibb (Switzerland) (CH), Institut Curie (FR), Nantes Université (FR), Université de Caen Normandie (FR)
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Lymphoma Diagnosis and Treatment
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