Adcetris brentuximab vedotin: Phase III data

The open-label, international Phase III ALCANZA trial in 131 patients with CD30-positive CTCL who received prior systemic therapy or radiation therapy showed that 1.8 mg/kg IV Adcetris every 3 weeks met the primary endpoint of a greater proportion of patients who achieved an objective response lasting >=4 months vs. investigator’s choice of methotrexate or bexarotene (56.3% vs. 12.5%, p<0.0001). Adcetris also met the secondary endpoints of improving complete response rate, PFS and burden of symptoms during treatment vs. investigator’s choice of therapy. Data will be submitted for presentation at the American Society of Hematology meeting in San Diego in December. The partners have an SPA from FDA for the trial. ...