Rituximab Plus Lenalidomide Shows Durable Responses as Frontline Treatment for Patients With Follicular Lymphoma
The combination of rituximab and lenalidomide (RL) as first-line therapy demonstrated improved long-term cancer outcomes compared to rituximab monotherapy (R) among patients with follicular lymphoma (FL), according to phase 2 study results published in Blood Advances.
Rituximab treatment during and after chemotherapy has been the standard of care for FL, however chemotherapy-free treatment regimens are needed. Researchers conducted a randomized phase 2 trial to determine the efficacy of rituximab plus lenalidomide at long term follow-up among patients with grade 1 to 3A FL.
The primary end point was complete response (CR) at 6 months and 30 months, with previous findings demonstrating a clinical benefit with the combination of rituximab and lenalidomide over rituximab therapy alone. Progression-free survival (PFS), time to next treatment (TTNT), response duration, overall survival (OS) were secondary end points.
Overall, 154 patients with FL were randomized to receive rituximab (375 mg/m² IV weekly for 4 weeks; n = 77) or rituximab plus lenalidomide (additional 15 mg daily; n = 77). At a median follow-up of 9.5 years, the duration of response was higher among patients treated with rituximab plus lenalidomide compared with rituximab monotherapy (not reached vs 3.2 years; hazard ratio [HR], 0.42; 95% confidence interval [CI], 0.21 to 0.86; P = .014), median PFS (9.3 vs 2.3 years; HR, 0.57; 95% CI, 0.37 to 0.89; P = .0128), and median TTNT (not reached vs 2.1 years; HR, 0.43; 95% CI, 0.27 to 0.67; P < .001). At 10 years, the OS for rituximab plus lenalidomide was 77% which was similar to the rituximab monotherapy group (78%; P = .881).
In terms of safety, 15 deaths occurred among patients treated with rituximab plus lenalidomide, with 1 death being a serious adverse event, and 14 deaths in the rituximab monotherapy group.
“The excellent OS with RL and also with R only confirms that chemotherapy-free strategies may be a relevant treatment option,” the researchers concluded.
They added, “the goal for future patients is to identify response predictors for an optimized treatment while maintaining maximal quality of life without the risk of toxicity and worse outcome, in terms of both long-term side effects and OS.”
Source:
Kimby E, Schär S, Pirosa MC, et al. Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year update. Blood Advances. Published online April 1, 2025. doi:10.1182/bloodadvances.2024014840
