A PHASE II LYSA STUDY OF OBINUTUZUMAB COMBINED WITH LENALIDOMIDE FOR RELAPSED OR REFRACTORY FOLLICULAR B‐CELL LYMPHOMA

Abstract

Background: The combination of rituximab (RTX) and lenalidomide (LEN) has been shown to be synergistic in patients (pts) with previously untreated and relapsed follicular lymphoma (FL). A combination of obinutuzumab (GA), a glycoengineered type II anti‐CD20 antibody, with LEN (GALEN) might be even more efficient while retaining a similarly manageable safety profile. We determined the recommended GA + LEN dosing in part IB of this study. Here, we report the results of the Phase II part assessing efficacy and safety of GALEN therapy in a cohort of relapsed/refractory (R/R) FL pts (NCT01582776). Methods: Eligible pts had a ECOG PS 20% of pts) during induction (% all Gr / % Gr 3/4) were gastrointestinal disorders (76.1/2.3), infections (62.5/6.8), asthenia (52.3/2.3), neutropenia (30.7/28.4), muscle spasms (30.7/0), and cough (20.7/0). Febrile neutropenia occurred in 3.4% pts. AEs of special interest were rash (19.3/0), peripheral neuropathy (17.0/1.1), IRR (14.8, 3.4), venous thrombosis (1.1/0). 6 second primary malignancies were reported in 3 pts (5 basal carcinoma and 1 myelodysplastic syndrome). Conclusion: Oral LEN plus GA infusion is highly effective in relapsed or refractory FL pts with no unexpected toxicity. (Table Presented).