Additional Relevant Details The regulatory submission is now pending validation by the EMA and is primarily supported by data from two Phase 3 studies, in patients with multiple myeloma who have received one or more prior lines of therapy, showing combination of daratumumab with a PI or immunomodulatory agent resulted in a >60% reduction in the risk of disease progression or death.2,3

• The MMY3004 (CASTOR) clinical trial evaluated daratumumab in combination with bortezomib and dexamethasone, compared to bortezomib and dexamethasone alone. Study results were previously presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) and at the 21st Annual Congress of the European Hematology Association (EHA) in June 2016.2
• The MMY3003 (POLLUX) clinical trial evaluated daratumumab in combination with lenalidomide and dexamethasone, compared to lenalidomide and dexamethasone alone. Findings were presented at EHA in June 2016.