Six-Year Results From RELEVANCE: Lenalidomide Plus Rituximab (R²) Versus Rituximab-Chemotherapy Followed by Rituximab...

Area of Science:

• Hematology
• Clinical Oncology
• Pharmacology

Background:

• Follicular lymphoma (FL) is an indolent non-Hodgkin lymphoma with various treatment options.
• The RELEVANCE trial initially compared lenalidomide plus rituximab (R2) with rituximab plus chemotherapy (R-chemo) in previously untreated advanced FL.
• Previous reports focused on primary endpoints, necessitating updated analyses for long-term outcomes.

Purpose of the Study:

• To report the second interim analysis of the RELEVANCE trial with 6 years of follow-up.
• To evaluate the long-term efficacy and safety of R2 versus R-chemo in advanced-stage, previously untreated FL.
• To assess progression-free survival (PFS), overall survival (OS), response rates, transformation rates, and secondary malignancies.

Main Methods:

• A randomized, 1:1 controlled trial (NCT01650701) involving patients with previously untreated grade 1-3a FL.
• Patients received either R2 or R-chemo, followed by rituximab maintenance.
• Coprimary endpoints included complete response at week 120 and PFS; secondary endpoints included OS and safety.

Main Results:

• At a median follow-up of 72 months, 6-year PFS was comparable: 60% for R2 and 59% for R-chemo (HR=1.03).
• Six-year overall survival was 89% in both arms; median PFS and OS were not reached.
• Transformation rates and secondary primary malignancies were similar between the R2 and R-chemo groups, with no new safety concerns.

Conclusions:

• Lenalidomide plus rituximab (R2) provides durable and comparable efficacy to R-chemo in previously untreated advanced FL.
• The R2 regimen represents an acceptable chemo-free alternative with a similar long-term safety profile.
• Continued follow-up confirms the sustained benefit and tolerability of R2 in this patient population.