The Bruton’s tyrosine kinase (BTK) inhibitor ONO-4059: Single-agent activity in patients with relapsed and refractory non-GCB-DLBCL.

8553 Background: Bruton’s tyrosine kinase (BTK) is a critical kinase involved in B-cell receptor signal transduction. ONO-4059, a highly potent and selective oral BTK inhibitor has demonstrated anti-tumour activity in pre-clinical models (Yasuhiro et al, AACR 2013) and in the clinic in both NHL and CLL patients (Salles et al, ASH 2013; Rule et al, ASH 2013). Here, we present data from non-GCB DLBCL patients enrolled in the ongoing Phase I study ONO-4059POE001. Methods: Thirteen patients with relapsed (n=8) or refractory (n=5) non-GCB-DLBCL were administered ONO-4059 as monotherapy, given once daily (QD) at doses ranging from 160-480mg, to determine safety, pharmacokinetics and pharmacodynamics, as well as any preliminary efficacy. Patients had a median age of 65yrs [range 30-72], median of 4 prior therapies [2-8], and a median baseline tumour burden of 2,504mm2 [619-15,750mm2]. All 13 patients had prior exposure to a rituximab-containing regimen and 5/13 patients (38%) had prior ASCT. Results: Thirteen pa...