Positive phase 2 efficacy results in follicular lymphoma (FL) for a first-line therapy regimen that combined rituximab with lenalidomide were recently reported in Blood.
In the phase 2 SAKK 35/10 trial (ClinicalTrials.gov Identifier: NCT01307605), single-agent rituximab was compared with rituximab plus lenalidomide (RL) in previously untreated, symptomatic FL, with 77 patients in each of the 2 treatment arms.
In both treatment groups, rituximab was given during weeks 1 through 4 and, for responders, during weeks 12 through 15. Patients received lenalidomide for 18 weeks in the RL group. The primary study endpoint was the 6-month rate of complete response (CR)/unconfirmed CR (CRu).
In the intention-to-treat population, the investigators reported a 6-month CR/CRu rate was 36% (95% CI, 26%-48%) with RL and 25% (95% CI, 16%-36%) with single-agent rituximab. An independent response review of computed tomography scans identified a 6-month CR/CRu rate of 61% (95% CI, 49%-72%) with RL, compared with a rate of 36% (95% CI, 26%-48%) for single-agent rituximab.
After a median follow-up of 4 years, the median progression-free survival from the time of randomization was 5.0 years with RL and 2.3 years with rituximab alone (hazard ratio [HR], 0.60; 95% CI, 0.38-0.97; P =.035).
Median duration of response was not reached for patients on RL and 3.0 years for patients on rituximab alone (HR, 0.46; 95% CI, 0.20-1.04; P =.055). Median time to next treatment was also not reached with RL, while it was 2.1 years for patients on single-agent rituximab (HR, 0.49; 95% CI, 0.30-0.78; P =.003).
With RL, the 4-year overall survival rate was 91%, and with rituximab alone it was 90% (HR, 0.98; 95% CI, 0.34-2.79; P =.97).
Patients receiving RL showed higher rates of grade 3 or higher adverse events, particularly neutropenia, compared with patients receiving single-agent rituximab. However, the investigators reported that toxicity was manageable for both treatment arms.
“The results of our study support the growing evidence that RL regimens might offer an alternative to standard immunochemotherapy,” the researchers concluded.
- Zucca E, Rondeau S, Vanazzi A, et al. Short regimen of rituximab plus lenalidomide in follicular lymphoma patients in need of first-line therapy [published online July 25, 2019]. Blood. doi:10.1182/blood-2018/10/879643