October 1, 2012
Cell Therapeutics reported results from a phase I trial of pacritinib (SB1518) for the treatment of relapsed/refractory lymphoma. This multi-arm, dose-finding study enrolled 34 patients with relapsed or refractory Hodgkin’s or non-Hodgkin’s lymphoma of any type except Burkitt’s or CNS lymphoma. Subjects received pacritinib ranging from 100mg to 600mg daily. Data showed the maximum dose was not met. Pacritinib inhibited JAK2 signaling at all dosing levels and FLT-3 inhibition were seen in most patients. Seventeen of the 34 patients (50%) had measurable decreases in target tumor measurements ranging from 4% to 70% shrinkage. Partial remissions were noted in three patients (mantle cell and indolent lymphoma), while 15 patients had stable disease. Median progression-free and overall survival was 120 and 130 days, respectively. Pacritinib was well tolerated. The most frequent adverse events were gastrointestinal. Based on these data, Cell Therapeutics will continue with efficacy studies of JAK/STAT pathway inhibitors, either alone or in combination regimens.
December 13, 2010
Novartis reported positive results from a phase II trial of oral panobinostat for the treatment of Hodgkin's lymphoma. This international, non-randomized, open label study enrolled 129 subjects with refractory/relapsed classical HL who had received prior treatment with autologous bone marrow transplant and other commonly used chemotherapies. The subjects received oral panobinostat 40 mg, three times per week, every week dosing on a 21-day cycle. The primary endpoint was objective response rate at 24 weeks post first-dose. At a median follow-up of 9.6 months, a reduction in measurable tumor size was observed in 96 subjects (74%); responses were observed in 35 subjects (5 complete responses, 30 partial responses; overall response rate 27%). The median progression-free survival was 6.1 months (10.5 months among responders). The overall rate of discontinuation due to adverse events was 16%.
October 4, 2010
Seattle Genetics and Millenium issued positive results from a clinical trial evaluating brentuximab vedotin for the treatment of Hodgkin's lymphoma. The single agent trial enrolled 102 subjects with relapsed or refractory Hodgkins lymphoma post-autologous stem cell transplant. The subjects received 1.8 mg/kg of brentuximab vedotin every three weeks for up to 16 total doses. The primary endpoint of the trial was objective response rate. An objective response was reached by 75% of the subjects and the median duration of response was greater than six months. The treatment was determined to be safe and well tolerated.
June 15, 2009
Novartis released positive results from a phase II trial of everolimus (Afinitor) for the treatment of non-Hodgkins lymphoma and Hodgkins disease. This open-label, single-arm study enrolled 145 subjects with relapsed/refractory aggressive or indolent NHL or Hodgkin's disease whose disease progressed despite prior treatment. The subjects received everolimus 10 mg daily and were evaluated monthly. Dose reductions to 5 mg daily and 5 mg every other day were permitted. The primary endpoint was overall response rate (ORR). Results showed that 33% of subjects treated with everolimus experienced a 50% or greater reduction in tumor size. This 33% overall response rate (ORR) is defined as complete or partial tumor shrinkage. The median time to disease progression for all subjects was 4.3 months and of the 48 responders the median duration of response was 6.8 months. Nineteen of the 48 responders remained progression free at six months Anticancer activity was observed across multiple types of lymphoma, including T-cell non-Hodgkin's lymphoma (63% ORR), Hodgkin's disease (53% ORR), follicular lymphoma (50% ORR), mantle cell lymphoma (32% ORR), DLBCL (30% ORR).