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Seattle Genetics Highlights Updated Survival Data from ADCETRIS Pivotal Trial In Patients With Relapsed Or Refractory Hodgkin Lymphoma


Thursday, 14 Jun 2012 07:00am EDT 

Seattle Genetics announced updated survival data from a pivotal clinical trial of single-agent ADCETRIS (brentuximab vedotin) in patients with relapsed or refractory Hodgkin 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 Hematology Association (EHA) Annual Meeting being held June 14-17, 2012 in Amsterdam, Netherlands. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. A pivotal 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. At the time of the long-term follow-up analysis, the median observation time from first dose was 26.5 months. Data, to be presented by Dr. Smith, include: As previously reported, the ORR was 75% (76 of 102 patients), with CRs observed in 33% of patients (n=34). The median OS had not been reached at the time of the analysis. The estimated OS at 24 months was 65%. The median PFS for all patients was 5.6 months. The median PFS for patients achieving a CR was 29 months. 

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