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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

g-term disease-free survival in all patients(3,4). When a patient relapses or becomes refractory, treatment options include high-dose chemotherapy, usually followed by stem cell transplantation(3,4). The use of transplantation has resulted in improved outcomes in patients with relapsed disease, but still 40% to 50% of these patients subsequently relapse(2). There is currently no standard of care for patients who relapse or are refractory following these treatments(3,4).

Study detailsThis Phase II clinical trial evaluated the efficacy and safety of oral LBH589 in patients with refractory/relapsed classical Hodgkin lymphoma who had received prior treatment with high-dose chemotherapy and autologous stem cell transplant(9).

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(9).

As of the data analysis, 129 patients had been enrolled and treated. Patients had received a median number of four (range 2-7) prior systemic regimens, including combination regimens involving drugs such as gemcitabine, vinca-alkaloids or platinum-based chemotherapies. At a median follow-up of 9.6 months, a reduction in measurable tumor size was observed in 96 (74%) patients; responses were observed in 35 patients (5 complete responses, 30 partial responses; overall response rate 27%). Median progression-free survival was 6.1 months (10.5 months among responders)(1).

Common adverse events (mostly grade 1 or 2) included diarrhea, nausea, fatigue, vomiting, anorexia, dysguesia, asthenia, constipation, leukopenia and muscle spasms. Common related grade 3/4 adverse events included thrombocytopenia, anemia and neutropenia. Thrombocytopenia was reversible with dose hold or modification and was manageable long term, with only 5% treatment discontinuation
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