Safety of idelalisib in B-cell malignancies: Integrated analysis of eight clinical trials.

e18030 Background: Idelalisib (Zydelig), a first-in-class, selective, oral inhibitor of PI3Kδ, is approved in the US and EU for the treatment of chronic lymphocytic leukemia (CLL) in combination with rituximab and as monotherapy for patients with follicular lymphoma who have received at least two prior systemic therapies. Methods: An integrated analysis of safety was conducted for 760 subjects with CLL, indolent non-Hodgkin lymphoma, or other B-cell malignancy who received IDELA alone (doses = 50 mg BID to 350 mg BID) or as part of a combination regimen (IDELA doses = 100 or 150 mg BID). Most subjects were heavily pre-treated with relapsed disease. Results: Common adverse events (AEs) are presented in the table, along with important laboratory results. AEs leading to dose modification included transaminase elevations (13%), diarrhea/colitis (11%), and rash (5%); discontinuations due to these AEs were infrequent (3%, 5%, and 2%, respectively); dose interruption allowed successful re-challenge in most patie...