Idelalisib Efficacy And Safety In Follicular Lymphoma Patients From A Phase 2 Study

8529 Background: There is an unmet need for new treatment options in FL, particularly for heavily pretreated, high-risk patients refractory to anti-CD20 and chemotherapy. Idelalisib, a PI3Kδ inhibitor, showed antitumor activity and acceptable tolerability as monotherapy in a pivotal phase 2, open-label study in indolent non-Hodgkin lymphoma (iNHL) refractory to rituximab (R) and an alkylating agent (NCT01282424). This post hoc analysis evaluated efficacy and safety in the FL patient subset. Methods: Double refractory patients with histologically confirmed iNHL received oral idelalisib 150 mg BID until disease progression (PD) or unacceptable tolerability; patients with FL (grade 1, 2, or 3a; n = 72) were included in this analysis. Responses were evaluated by an independent review committee using standardized criteria. The primary endpoint was the overall response rate (ORR). Results: At study entry, patients’ median age was 62 y, 54% had a high-risk FLIPI score, 22% had bulky disease, and 17% had FL grade...