Interim results for the phase II study of panobinostat (LBH589) in patients (Pts) with relapsed/refractory Hodgkin's lymphoma (HL) after autologous hematopoietic stem cell transplant (AHSCT)

8007 Background: Panobinostat (PAN) is a pan-deacetylase inhibitor targeting epigenetic and non-epigenetic oncogenic pathways. In vitro, PAN decreases proliferation and induces apoptosis in HL cell lines at low nanomolar concentrations. In a Phase I study, promising activity was observed in pts with HL (EHA 2009, Abstract #1064). Methods: This international trial with Simon optimal 2-stage design has completed enrollment with 129 pts at 45 sites. Oral PAN is administered at a dose of 40 mg three times per week, every week, in 21-day cycles. Dose delay and modification is allowed for management of AEs. CT/MRI scans are conducted after every 2 cycles. Primary endpoint of the study is objective response rate. Secondary endpoints include time to and duration of response (TTR, DOR), PFS, and safety. Results: As of December 14, 2009, demographic data are available for 127 pts: median age was 32 years [18–75]; 37% had ≥5 prior lines of therapy; median prior regimen was 4 [2–6]; 37% had no response on last therap...