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Takeda UK Ltd today announced updated survival data from a pivotal Phase II clinical trial of single-agent brentuximab vedotin in patients with relapsed or refractory Hodgkin’s lymphoma (HL) after autologous stem cell transplant (ASCT) showing that the median overall survival has not been reached after a 26.5 month median follow-up.
The data will be reported during an oral presentation at the 17th European Haematology Association (EHA) Annual Meeting being held 14–17 June, 2012, in Amsterdam, Netherlands.
Brentuximab vedotin is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of the majority of types of HL. The marketing authorisation for brentuximab vedotin in Europe is currently under review by the European Medicines Agency.
“Heavily pretreated Hodgkin’s lymphoma patients who relapse following autologous stem cell transplant often have a poor prognosis and there is a high unmet medical need for effective treatment options,” said Scott Smith M.D., Ph.D., Loyola University Medical Center.
“These updated overall survival results from the pivotal trial are encouraging and suggest that brentuximab vedotin may play an important role in the treatment of patients with relapsed or refractory disease.”
This pivotal, open-label, single-arm, Phase II trial was conducted in 102 patients with relapsed or refractory HL after ASCT. The primary endpoint was objective response rate (ORR) per independent review.
The secondary endpoints were complete remission (CR) rate, duration of response, progression-free survival (PFS), overall survival (OS), and safety and tolerability and initial results were reported at ASCO in June 2011.
This long-term follow-up analysis was conducted when the median observation time from first dose was 26.5 months.