Genmab announces that Janssen Research & Development, LLC, in collaboration with the European Myeloma Network (EMN) and Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON), plans to start a Phase III study of daratumumab in relapsed and refractory multiple myeloma.
The study (MMY3013, APOLLO) is a randomized Phase III that will compare daratumumab in combination with pomalidomide and dexamethasone versus pomalidomide and dexamethasone in patients who have previously been treated with an immunomodulatory drug and a proteasome inhibitor (PI). The study is expected to start in Q2 2017 and is designed to confirm results from the MMY1001 (EQUULEUS) study, a Phase I study investigating the daratumumab-pomalidomide-dexamethasone combination, are currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of June 17, 2017.
“We are very pleased to see this Phase III study initiated. The combination of daratumumab with pomalidomide and dexamethasone may represent a new approach for patients who have been previously treated with an immunomodulatory drug and a PI. We look forward to the readout of this study,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.