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Novartis Phase II LBH589 data show substantial disease control and tumor reduction in extensively pretreated Hodgkin lymphoma patients
Date:12/6/2010

EAST HANOVER, N.J., Dec. 6, 2010 /PRNewswire/ -- The Novartis Pharmaceutical Corporation ("Novartis") oral investigational drug LBH589 (panobinostat) demonstrated substantial disease control and tumor reduction in extensively pretreated Hodgkin lymphoma patients who had relapsed or had become refractory after an autologous stem cell transplant, according to new data from a Phase II clinical trial presented today(1).

In this pivotal single-arm study, one of the largest ever conducted in this patient population, 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(1).

These data were presented today at the 52nd Annual Meeting and Exposition of the American Society of Hematology (ASH) in Orlando, Florida. Worldwide regulatory filings are planned based on the study results.

Currently, up to 35% of patients with Hodgkin lymphoma relapse or become refractory after initial treatment, which typically involves at least two regimens of combination chemotherapy along with high-dose chemotherapy and stem cell transplant(2). Most patients enrolled in this study had received nearly all of the chemotherapy drugs known to be active in this disease, and 79% had failed an additional round of chemotherapy after a stem cell transplant. In addition, 10% of patients had also received prior allogeneic stem cell transplantations (stem cells from another person) in addition to an autologous transplant (stem cells from the patient). Palliative care is currently the only option remaining for these patients(3,4). '/>"/>

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