Phase 2 study of LBH589 for the treatment of Hodgkin lymphoma

Novartis announced results from its Phase 2 study of LBH589 (panobinostat) for the treatment of extensively pretreated Hodgkin lymphoma patients who had relapsed or had become refractory after an autologous stem cell transplant. The primary outcome measure was objective response rate to therapy. Secondary outcome measures included response rate based on central review of CT scan/MRI, time to response, duration of response, progression-free survival rate and safety and tolerability of treatment.

In this pivotal single-arm study, 82% (n=106) of patients, most in their fifth line of therapy or beyond, achieved disease control (defined as stable disease or better) and 74% (n=96) achieved tumor reduction at a median follow-up of 9.6 months, demonstrating the sustained anticancer activity of LBH589. Partial and complete responses to treatment, the primary endpoint, were observed in 27% of patients (n=35), with a median duration of response of 6.9 months and a median progression-free survival measured at 10.5 months among those 35 patients.

LBH589 is an oral pan-deacetylase (DAC) inhibitor, which targets changes in gene function (also known as epigenetic regulation) that regulate processes in the development of cancer, including proliferation and survival of Hodgkin lymphoma cells in laboratory studies.

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