HuMax CD38 (daratumumab) filed with EU for multiple myeloma-Janssen-Cilag

Janssen-Cilag International NV has submitted a new Marketing Authorisation Application to the European Medicines Agency (EMA) for HuMax CD38 (daratumumab), an investigational, human anti-CD38 monoclonal antibody, for the treatment of patients with relapsed and refractory multiple myeloma.

The filing is based on data from the Phase II MMY2002 (SIRIUS) monotherapy study presented at the 51st Annual Meeting of the American Society of Clinical Oncology, data from the Phase I/II GEN501 monotherapy study, which was recently published in The New England Journal of Medicine, and data from three supportive studies.

For MMY2002, the primary efficacy endpoint was overall response rate (ORR). Daratumumab achieved an ORR of 29% in the group of patients who received 16 mg/kg (n=106) as a single-agent therapy, with a well tolerated safety profile. The ORR outcomes of MMY2002 are similar to the ORR data in the Phase 1/2 GEN501 study, in which safety was the primary endpoint. In this study, daratumumab demonstrated a tolerable safety profile and achieved an ORR of 36% (11 partial responses, two very good partial responses and two complete responses) in the group of patients who received 16 mg/kg, with responses improving over time. Median progression-free survival was 5.6 months and 65% of responders remained in remission at 12 months. The OS rate at 12 months was 77%.