Adcetris: Additional Ph III ALCANZA data

Additional data from 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 secondary endpoints of improving median PFS (16.7 vs. 3.5 months, HR=0.27, 95% CI: 0.169, 0.43, p<0.0001), complete response rate (15.6% vs. 1.6%, p=0.0046) and Skindex-29 symptom domain questionnaire score (p<0.0001) vs. investigator’s choice of methotrexate or bexarotene. Data were presented at the American Society of Hematology meeting in San Diego. Previously reported data showed that Adcetris 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) (see BioCentury, Aug. 8, 2016). The partners have an SPA from FDA for the trial...