WASHINGTON (dpa-AFX) - Seattle Genetics Inc. (SGEN) summarized Adcetris (brentuximab vedotin) data in relapsed Hodgkin lymphoma or HL and other CD30-positive malignancies from multiple presentations at the 54th American Society of Hematology or ASH Annual Meeting and Exposition.
Highlights include compelling survival data from long-term follow up in a pivotal clinical trial of Adcetris in relapsed or refractory HL and a retrospective comparison of overall survival among patients treated with Adcetris to those not treated with ADCETRIS following an autologous stem cell transplant or ASCT.
In addition, data describe the activity and tolerability of Adcetris in the salvage HL setting from an investigator-sponsored trial and in relapsed patients age 60 or over with CD30-positive malignancies, including HL. Adcetris is an antibody-drug conjugate or ADC directed to CD30, a defining marker of classical HL.
Data highlights from the long-term survival analysis in the pivotal trial were: After a median observation time of approximately 2.5 years from first dose of Adcetris, 59 percent of patients (60 of 102 patients) were alive and the median overall survival had not yet been reached. The estimated two year survival rate was 65 percent, including 91 percent for patients who achieved a complete remission. Improved overall survival and progression-free survival correlated with PET (positron emission tomography) evaluation at Cycle four.
An independent retrospective comparison conducted by MD Anderson Cancer Center evaluated overall survival in 102 relapsed HL patients treated with Adcetris in a pivotal clinical trial compared to data from 756 relapsed HL patients treated at six international centers.
Key findings included: Median overall survival following the date of ASCT in Adcetris treated patients was 91.49 months compared to 27.99 months in those not treated with Adcetris (p<0.0001).
In an analysis evaluating predictors of patients who achieved a durable complete remission with Adcetris, only the stage of disease at initial diagnosis had a significant effect on overall survival.
Data highlights were: Of the 14 patients evaluable at the time of this analysis, the objective response rate was 85.7 percent (12 of 14 patients), including 50 percent (seven of 14 patients) with a complete remission and 35.7 percent (five of 14 patients) with a partial remission.
Two patients achieved stable disease after four cycles of therapy. No patients developed progressive disease while on treatment.
The company stated that Adcetris is not approved for salvage HL patients who are deemed eligible for ASCT. There are multiple ongoing investigator-sponsored trials being conducted evaluating Adcetris as a salvage HL therapy, and a phase I/II clinical trial evaluating ADCETRIS with bendamustine in this setting will be initiated by the end of 2012.
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