Tenalisib, a dual PI3K δ/γ inhibitor: Safety and efficacy results from an on-going phase I/Ib study in relapsed/refractory T-cell lymphoma.

7510Background: Tenalisib is a novel, next generation, highly specific, dual equi-potent PI3K δ/γ inhibitor. Early results demonstrated an acceptable safety profile with encouraging clinical activity in relapsed/refractory TCL (NCT02567656). Methods: An open-label, Phase 1/1b study consists of dose escalation cohorts followed by two expansion cohorts enrolling patients with peripheral TCL (PTCL) and with cutaneous TCL (CTCL). The primary objective is to determine the MTD, and to describe the safety and pharmacokinetic profiles. The secondary objectives are assessment of the overall response rate (ORR) and duration of response (DoR). Responses were evaluated for PTCL and CTCL based on IWG criteria (Cheson 2007) and the mSWAT respectively. Results: As of January 10, 2018, a total of 55 patients (27 PTCL and 28 CTCL) have been enrolled. 19 patients across dose escalation (200 mg - 800 mg BID) and 36 patients in dose expansion (at MTD, 800 mg BID Fasting) were enrolled and the results presented are the pooled...