KEY TAKEAWAYS
- The RELEVANCE trial (NCT01650701) is a phase 2 study evaluating the efficacy and safety of lenalidomide plus rituximab (R2) vs. (R-chemo) in previously untreated patients with FL.
- The coprimary endpoints of the trial were complete response and PFS at week 120.
- At a median follow-up of 72 months, the 6-year PFS was similar between the R2 and R-chemo groups.
- The 6-year overall survival was estimated to be 89% in both groups
- The R2 group provided a chemo-free alternative to R-chemo and demonstrated comparable, durable efficacy and safety.
- The transformation rate per year in the R2 and R-chemo groups was 0.68% and 0.45%, respectively.
Multiple endpoints with varying maturation times are common in clinical trials. Even if key planned co-primary or secondary analyses are unavailable, the initial report may be published based on the primary endpoint. Additional data from studies for which the primary endpoint has already been reported can be disseminated through Clinical Trial Updates, published in JCO and elsewhere. Patients with advanced-stage, previously untreated follicular lymphoma (FL) responded similarly to rituximab plus chemotherapy (R-chemo) and lenalidomide plus rituximab (R2) in the RELEVANCE trial (ClinicalTrials.gov identifier: NCT01650701). Researchers presented the second interim analysis six years into the RELEVANCE trial’s planned duration. Untreated patients with grades 1-3a FL were randomly assigned (1:1) to R2 or R-chemo, followed by rituximab maintenance. Complete response (confirmed/unconfirmed) at 120 weeks and progression-free survival (PFS) were coprimary endpoints.
Six-year progression-free survival(PFS) was 60% for R2 and 59% for R-chemo at a median follow-up of 72 months (95% confidence interval [CI]: 0.84 to 1.27). Both groups had similar 6-year survival rates of around 89%. No group achieved a median period of progression-free survival or overall survival. After disease progression, the estimated 5-year survival rate was 69% in the R2 group and 74% in the R-chemo group. Secondary primary malignancies occurred in 11% and 13% (P =.34) of the R2 and R-chemo groups, respectively, and the annual transformation rate was 0.68% and 0.45%, respectively. There were no fresh warning signs detected. When compared to R-chemo, the standard of care for newly diagnosed FL patients, R2 provides an acceptable chemo-free alternative with comparable, durable efficacy and safety.
Source:https://pubmed.ncbi.nlm.nih.gov/35947804/
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT01650701
Morschhauser F, Nastoupil L, Feugier P, Schiano de Colella JM, Tilly H, Palomba ML, Bachy E, Fruchart C, Libby EN, Casasnovas RO, Flinn IW, Haioun C, Maisonneuve H, Ysebaert L, Bartlett NL, Bouabdallah K, Brice P, Ribrag V, Le Gouill S, Daguindau N, Guidez S, Pica GM, García-Sancho AM, López-Guillermo A, Larouche JF, Ando K, Gomes da Silva M, André M, Kalung W, Sehn LH, Izutsu K, Cartron G, Gkasiamis A, Crowe R, Xerri L, Fowler NH, Salles G. Six-Year Results From RELEVANCE: Lenalidomide Plus Rituximab (R2) Versus Rituximab-Chemotherapy Followed by Rituximab Maintenance in Untreated Advanced Follicular Lymphoma. J Clin Oncol. 2022 Oct 1;40(28):3239-3245. doi: 10.1200/JCO.22.00843. Epub 2022 Aug 10.PMID:35947804;PMCID:PMC9553375
