ORLANDO – Brentuximab vedotin, an investigational agent, was associated with complete remission in 34% of patients whose Hodgkin’s lymphoma recurred after autologous stem cell transplantation, according to the results of a phase II trial involving 102 patients.
"The antibody component of the drug allows for the selective delivery of the chemotherapeutic agent directly into the Hodgkin’s lymphoma cells," Dr. Robert Chen said at a press conference held in conjunction with the annual meeting of the American Society of Hematology.
Dr. Robert Chen
"The overall response rate was 75%," with a median duration of 29 weeks, said Dr. Chen of City of Hope National Medical Center in Duarte, Calif. "Overall, 94% of the patients achieved any kind of tumor reduction," he said.
Dr. Chen and colleagues conducted the single-arm, multicenter study to evaluate the safety and efficacy of brentuximab vedotin, an antibody-drug conjugate, in patients with relapsed or refractory Hodgkin’s lymphoma following autologous stem cell transplants. In general, the prognosis for this patient population is poor, with a median survival time of 2.4 years, Dr. Chen noted.
The patients received 1.8 mg/kg of brentuximab vedotin every 3 weeks in the form of a 30-minute intravenous infusion. Patients had up to 16 treatment cycles.
The most common side effect was peripheral neuropathy, reported by 43% of the patients. However, approximately two-thirds of these patients had resolution of the peripheral neuropathy after treatment completion. The side effect profile is manageable, compared with other combination chemotherapy regimens, Dr. Chen said. Other commonly reported side effects included fatigue, nausea, and upper respiratory tract infections.
The patients ranged in age from 15 to 77 years, with a median age of 31 years, and 53% were women. The patients had received an average of 3.5 previous chemotherapy treatments in addition to autologous stem cell transplantation. The average length of treatment was 27 weeks (nine cycles), and patients were followed every 12 weeks.
A total of 96 of 102 patients (94%) achieved some degree of tumor reduction, and the estimated 12-month overall survival was 88%.
The results of this phase II study will be submitted to the Food and Drug Administration early in 2011, Dr. Chen said. Two additional trials are underway to evaluate brentuximab vedotin’s effectiveness in newly diagnosed Hodgkin’s lymphoma patients and as maintenance therapy.
"Once a patient fails a transplant, the prognosis is generally poor, said Dr. Ginna G. Laport, an associate professor of medicine at Stanford (Calif.) University. Dr. Laport served as the press conference moderator and several of her patients participated in the study. Brentuximab vedotin represents "a big breakthrough for this population," she said. "I think this is a very exciting drug."
Dr. Chen and his colleagues received research funding from the study sponsor, Seattle Genetics.