In the phase III AUGMENT trial reported in the Journal of Clinical Oncology, Leonard et al found that the addition of lenalidomide to rituximab significantly prolonged progression-free survival in patients with relapsed or refractory indolent lymphoma.
The double-blind trial enrolled 358 patients with relapsed or refractory follicular (82%) or marginal zone (18%) lymphoma from 97 centers in 15 countries. Patients were randomly assigned between February 2014 and January 2017 to receive lenalidomide plus rituximab (n = 178) or placebo plus rituximab (n = 180). Lenalidomide plus rituximab dosing included lenalidomide 20 mg daily on days 1 to 21, plus rituximab 375 mg/m2 on days 1, 8, 15, and 22 of cycle 1 and day 1 of cycles 2 to 5 every 28 days. Treatment with lenalidomide or placebo continued for 12 cycles.
The primary endpoint was progression-free survival on independent radiology review.
Median follow-up was 28.3 months. Median progression-free survival was 39.4 months in the lenalidomide plus rituximab group vs 14.1 months in the rituximab group (hazard ratio [HR] = 0.46, P < .001). Lenalidomide plus rituximab was associated with consistent progression-free survival benefits across all prespecified subgroups, except for the relatively small marginal zone lymphoma subgroup (n = 63; HR = 1.00, 95% confidence interval [CI] = 0.47–2.13). Response rates on independent review were 78% vs 53% (P < .001), with complete response occurring in 34% vs 18% (P = .001). Overall survival data are not mature. Fewer deaths have been observed in the lenalidomide group (HR = 0.61, 95% confidence interval = 0.33–1.13). Estimated 2-year overall survival was 93% vs 87%.
The lenalidomide plus rituximab group had higher rates of any-grade infections (63% vs 49%), neutropenia (58% vs 23%), and cutaneous reactions (32% vs 12%). Grade 3 or 4 adverse events occurred in 69% vs 32% of patients; higher rates of grade 3 or 4 neutropenia (50% vs 13%) and leukopenia (7% vs 2%) were observed with lenalidomide plus rituximab, with no other grade 3 or 4 adverse event differing by ≥ 5% between groups.
The investigators concluded, “Lenalidomide improved efficacy of rituximab in patients with recurrent indolent lymphoma, with an acceptable safety profile.”
John P. Leonard, MD, of the Meyer Cancer Center, Weill Cornell Medicine and NewYork-Presbyterian Hospital, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Celgene Corporation. The study authors’ full disclosures can be found at jco.ascopubs.org.
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