Lenalidomide Plus Rituximab vs Rituximab and Chemotherapy for Untreated Follicular Lymphoma

Long-Term Findings From the RELEVANCE Trial

In a 6-year follow-up of the RELEVANCE trial, lenalidomide plus rituximab (R²) continued to demonstrate comparable, durable efficacy and safety vs rituximab plus chemotherapy (R-chemo) in patients with advanced-stage, previously untreated follicular lymphoma (FL), providing an acceptable chemotherapy-free alternative.

“With long-term follow-up reported here (median 72 months), the coprimary end point of PFS on the basis of IRC [Independent Review Committee] remains unchanged as PFS did not differ significantly between groups. Overall, both groups maintained very favorable outcomes with similar 6-year PFS rates (60% R² v 59% R-chemo) and excellent 6-year OS rates of 89%,” Franck Morschhauser, MD, Centre Hospitalier Universitaire de Lille, France and colleagues explained in The Journal of Clinical Oncology.

The RELEVENCE trial randomized patients in a 1:1 ratio to to R² or R-chemo, followed by rituximab maintenance. The coprimary end points were complete response (confirmed/unconfirmed) at week 120 and progression-free survival (PFS).

At median follow-up of 72 months, 6-year PFS was 60% for R² and 59% for R-chemo (hazard ratio, 1.03; 95% confidence interval, 0.84 to 1.27). The 6-year overall survival (OS) was estimated to be 89% in both groups. Median PFS and OS were not reached in either group.

The overall response after progression was 61% in the R² group and 59% in the R-chemo group. The 5-year estimated survival rate after progression was 69% and 74%, respectively. The transformation rate per year in the R² and R-chemo groups was 0.68% and 0.45%, and secondary primary malignancies occurred in 11% and 13% (P = .34), respectively.

In this second interim analysis, no new safety signals were observed.

“Together, these data show that disease aggressiveness was similar after progression of both R² and R-chemo, and response to subsequent therapy is not compromised by either treatment,” the study authors added.

“In summary, R² provides an acceptable, long-term, chemo-free alternative to R-chemo on the basis of immunomodulation in patients with advanced untreated FL in need of treatment,” they concluded.

Source:

Morschhauser F, Nastoupil L, Feugier P, et al. Six-Year Results From RELEVANCE: Lenalidomide Plus Rituximab (R²) Versus Rituximab-Chemotherapy Followed by Rituximab Maintenance in Untreated Advanced Follicular Lymphoma. J Clin Oncol. Published online August 10, 2022. doi:10.1200/jco.22.00843