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ARTICLE | Clinical News

Adcetris brentuximab vedotin: Interim Phase II data

May 14, 2012 7:00 AM UTC

Interim data from 16 evaluable patients with relapsed CD30-positive CTCL in an investigator-sponsored, open-label, U.S. Phase II trial showed that 1.8 mg/kg IV Adcetris given every 3 weeks produced 12 partial responses plus 3 cases of stable disease. Additionally, 68% of patients maintained response at week 25. Median duration of response has not yet been reached. Seattle Genetics also said median CD30 expression on lymphoid cells in biopsies of skin lesions was 15% and that clinical activity was not dependent on CD30 expression levels. The most common grade 3 or higher adverse event was generalized skin eruption which occurred in 18% of patients. One patient experienced grade 4 peripheral neuropathy and there was 1 death due to respiratory failure presumably secondary to pneumonia. The trial, which was sponsored by Stanford University, enrolled 17 patients with mycosis fungoides or Sezary syndrome, 2 forms of CTCL in which CD30 expression is variable. Data were presented at Society for Investigative Dermatology meeting in Raleigh.

In January, researchers at the University of Texas MD Anderson Cancer Center reported data from 17 evaluable CTCL patients in a separate Phase II trial showing that Adcetris led an objective response rate (ORR) of 65%, including 7 complete remissions and 4 partial remissions. Last week, the partners began a Phase III trial of Adcetris to treat patients with relapsed CD30-positive CTCL under an SPA from FDA. Adcetris has accelerated approval in the U.S. to treat Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL). The product is under review in the EU for the indications. ...