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ARTICLE | Clinical News

AFM13: Phase I data

July 22, 2013 7:00 AM UTC

An open-label, dose-escalation, U.S. and German Phase I trial in 28 patients with relapsed or refractory Hodgkin's lymphoma showed that AFM13 led to 2 partial responses and 14 cases of stable disease. Patients received 0.01-7 mg/kg weekly AFM13 for 4 weeks (n=24) or 4.5 mg/kg AFM13 twice a week for 4 weeks (n=4). In 13 patients that received AFM13 at doses of >1.5 mg/kg, 3 patients had a >50% reduction in tumor volume and 8 patients had a reduction in both tumor volume and tumor activity. In 9 patients previously treated with Adcetris brentuximab vedotin, 7 achieved stable disease. AFM13 was well tolerated with infusion-related reactions, including headache, fever, fatigue and myalgia, reported as the most common adverse events. The MTD was not reached. Data were presented at the Malignant Lymphoma meeting in Lugano. AFM13 has Orphan Drug designation in the U.S. and Europe for Hodgkin's lymphoma. ...