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news.Novartis oral investigational drug LBH589 (panobinostat) demonstrated substantial disease control and tumour reduction in extensively pretreated Hodgkin lymphoma patients, according to new data from a Phase II clinical trial.
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According to Novartis, 82% of the patients achieved disease control and 74% of them achieved tumour reduction at a median follow-up of 9.6 months.
The primary endpoint, which was defined as partial and complete responses to treatment, was seen in 27% of the patients (n=35), and the 35 patients had a median duration of response of 6.9 months and a median progression-free survival measured at 10.5 months.
The pivotal single-arm study was designed to evaluate the efficacy and safety of LBH589 in patients with refractory/relapsed classical Hodgkin lymphoma who had received prior treatment with high dose chemotherapy and autologous stem cell transplant.
The study enrolled and treated 129 patients, and its primary endpoint was objective response rate to therapy.
The secondary endpoints of the study 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.