Novartis oral investigational drug LBH589 (panobinostat) has demonstrated substantial disease control and tumour reduction in extensively pre-treated Hodgkin’s lymphoma patients, according to data from a Phase II clinical trial.
The results showed that 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, defined as partial and complete responses to treatment, was seen in 27% (35) of the patients. The 35 patients had a median duration of response of 6.9 months and a median progression-free survival of 10.5 months.
The single-arm study was designed to evaluate the efficacy and safety of LBH589 in patients with refractory / relapsed classical Hodgkin’s 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 a CT or MRI scan, time to response, duration of response, progression-free survival rate, and the safety and tolerability of treatment.
LBH589 is an oral pan-deacetylase inhibitor that targets the changes in gene function that regulate process in the development of cancer.
Hodgkin’s lymphoma mostly affects teenagers and adults between the ages of 15 and 35, and adults over 50. It is the third most common cancer in people aged under 20.