Rocky Mountain Cancer Centers, US Oncology Research, Boulder, CO
David Andorsky , Morton Coleman , Abdulraheem Yacoub , Jason M. Melear , Heather Dawn Brooks , Suzanne R. Fanning , Kathryn S. Kolibaba , Frederick Lansigan , Chris Reynolds , Jiahui Li , Dongfang Liu , Mary Llorente , Justin L. Ricker , Jeff Porter Sharman
Background: In the relapsed/refractory (R/R) setting for indolent non-Hodgkin lymphoma (iNHL), duration of response (DOR) to and types of prior therapy are important factors in predicting outcomes to subsequent therapy. Lenalidomide plus rituximab (R2) has shown promising efficacy and tolerability in multiple NHL studies. This report explores the association between prior number of therapies and response to R2. Methods: MAGNIFY (NCT01996865) is a phase IIIb, multicenter, global study of R/R NHL patients, including follicular lymphoma (FL) grade 1-3a and marginal zone lymphoma (MZL). Patients receive 12 cycles of R2 (lenalidomide 20 mg/d, d1-21/28 + standard rituximab). Patients with stable disease or better are then randomized 1:1 to maintenance with R2 vs rituximab alone. This analysis focuses on the initial period before randomization (12 cycles R2) for patients with <2 (<2L) vs ≥2 lines (≥2L) of prior systemic anti-lymphoma therapies. Results: As of May 1, 2017, 232 patients with FL gr1-3a (n = 186) and MZL (n = 46) were enrolled for the initial treatment period. Overall, median age was 66 years (range 35-91) and 89% were stage III/IV. Patients received a median of 2 prior systemic treatments (31% ≥3) and 97% received prior rituximab-containing regimens. Analyzed subgroups included 43% <2L (n = 99) and 57% ≥2L (n = 133) with generally similar baseline characteristics. In efficacy-evaluable patients, the overall response rates (70% and 66%) and complete response (51% and 36%) were similar in <2L and ≥2L patients. Median time to response was 2.8 months (range, 2-12) for both groups. For <2L and ≥2L groups, 1-year rates for PFS were 68% and 70%, and DOR were 77% and 81%, respectively. The most common grade ≥3 treatment-emergent adverse events for <2L and ≥2L patients, respectively, were neutropenia (29%; 37%), thrombocytopenia (10%; 6%), and leukopenia (4%; 7%). Conclusions: R2 therapy showed favorable activity and tolerable safety profiles in patients who had R/R FL and MZL, regardless of the number of prior anti-lymphoma therapies. Enrollment in MAGNIFY is ongoing. Clinical trial information: NCT01996865
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