Lenalidomide Combo Shows Promise as Frontline Therapy for Follicular Lymphoma

The combination of rituximab (Rituxan) and lenalidomide (Revlimid) showed similar efficacy compared with rituximab plus chemotherapy, which failed to satisfy the primary endpoint for the phase III RELEVANCE trial for patients with untreated follicular lymphoma; however, the chemotherapy-free regimen had a more favorable safety profile, making it a potential first-line option, according to lead investigator Nathan H Fowler, MD, at the 2018 ASCO Annual Meeting.

"Rituximab/lenalidomide was not superior to rituximab/chemotherapy, based on mature CR/CRu analysis. It is very important to know, as we might expect, there are differences in safety profiles between arms," said Fowler, associate professor, The University of Texas MD Anderson Cancer Center. "These results show that lenalidomide/rituximab, which is a novel immunomodulatory approach, is a potential first-line option for patients with FL who require treatment."

After 120 weeks, the rituximab/lenalidomide combination, known as R2, showed a complete remission (CR) or unconfirmed CR rate of 48% compared with 53% for rituximab/chemotherapy (P = .13). The objective response rate (ORR) with the R2 regimen was 84% compared with 89% for rituximab/chemotherapy. The 3-year duration of response was 77% with R2 compared with 74% for rituximab/chemotherapy.

The study, which started in 2012, was designed prior to a full understanding of the benefits of the R2 combination, Fowler noted. "In retrospect, this would have been better as a non-inferiority trial, but it was designed with the data that we had,” he said. "We didn't have clear progression-free survival data from any of the phase II trials when this study was designed. All we had was overall response and CR rates."

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