On February 3, 2015 Genmab reported preliminary results from the Phase II study of daratumumab in double refractory multiple myeloma conducted by its collaboration partner Janssen Biotech (Press release Genmab, FEB 3, 2015, View Source [SID:1234501450]). The overall response rate (ORR) in the study was 29.2% in the 16 mg/kg dosing group and the median duration of response was 7.4 months as determined by an Independent Review Committee (IRC). The study evaluated multiple myeloma patients who have received at least three different lines of therapy including both a proteasome inhibitor and an immunomodulatory agent (IMiD) or who are double refractory to a proteasome inhibitor and an IMiD. This is the indication for which daratumumab was granted Breakthrough Therapy Designation from the FDA in May 2013.

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Daratumumab showed a manageable safety profile. The data will be discussed with health authorities at upcoming meetings, pending their agreement.

"We are very pleased with these positive results in this study of daratumumab as a monotherapy for the treatment of double refractory multiple myeloma," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We look forward to presenting additional data of this trial at a key upcoming medical conference this year."