Lenalidomide plus R-GDP (R2-GDP) in Relapsed/ Refractory Diffuse Large B-Cell Lymphoma: Final Results of the R2-GDP-GOTEL Trial and Immune Biomarker Subanalysis

Abstract

Purpose: New therapeutic options are needed in relapsed/refracResults: After a median follow-up of 37 months, ORR was tory diffuse large B-cell lymphoma (R/R DLBCL). Lenalidomide-60.2% [37.1% complete responses (CR) and 23.1% partial based schedules can reverse rituximab refractoriness in lymphoma. responses (PR)]. Median OS was 12 months (47 vs. 6 months Patients and Methods: In the phase II R2-GDP trial, 78 in CR vs. no CR); median PFS was 9 months (34 vs. 5 months in patients unsuitable for autologous stem cell transplant received CR vs. no CR). In the primary refractory population, ORR was treatment with the following schedule: lenalidomide 10 mg Days 45.5% (21.2% CR and 24.3% PR). Most common grade 3–4 (D)1–14, rituximab 375 mg/m2 D1, cisplatin 60 mg/m2 D1, adverse events were thrombocytopenia (60.2%), neutropenia gemcitabine 750 mg/m2 D1 and D8, and dexamethasone 20 mg (60.2%), anemia (26.9%), infections (15.3%), and febrile neutroD1–3, up to 6 cycles (induction phase), followed by lenalidomide penia (14.1%). Complete responses were associated with a sharp 10 mg (or last lenalidomide dose received) D1–21 every 28 days decrease in circulating myeloid-derived suppressor cells and (maintenance phase). Primary endpoint was overall response regulatory T cells. rate (ORR). Secondary endpoints included progression-free Conclusions: R2-GDP schedule is feasible and highly active survival (PFS), overall survival (OS), safety, and monitorization in R/R DLBCL, including the primary refractory population. of key circulating immune biomarkers (EU Clinical Trials Reg-Immune biomarkers showed differences in responders versus ister number: EudraCT 2014-001620-29). progressors.