Lenalidomide plus rituximab for previously untreated advanced follicular lymphoma: the 10-year RELEVANCE trial analysis.
(2026) Blood — (2026)
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- Authors
Westin, Jason R 
Schiano de Colella, Jean-Marc Schiano Morschhauser, Franck
- 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.
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Citations
Gower, N., Feugier, P., Westin, J. R., Schiano de Colella, J.-M. S., Tilly, H., Palomba, M. L., Julia, E., Damaj, G. L., Durand, A., Flinn, I. W., Lemonnier, F., Morineau, N., Ysebaert, L., Bartlett, N., Thieblemont, C., Ribrag, V., Gastinne, T., Arthur, D., Fouillet, L., et al. (2026). Lenalidomide plus rituximab for previously untreated advanced follicular lymphoma: the 10-year RELEVANCE trial analysis. Blood. Accepted/in-press. https://doi.org/10.1182/blood.2026033126 (Original work published 2026)