Here is a link the Janssen Cilag press release with the news. And here are a few paragraphs from the press release:
Janssen-Cilag International NV announced today it has submitted a new Marketing Authorisation Application to the European Medicines Agency (EMA) for daratumumab, an investigational, human anti-CD38 monoclonal antibody, for the treatment of patients with relapsed and refractory multiple myeloma ...
Daratumumab works by binding to CD38, a signalling molecule found on the surface of multiple myeloma cells. In doing so, daratumumab triggers the patient's own immune system to attack the cancer cells, resulting in rapid tumour cell death through multiple immune-mediated and other mechanisms of action.
The regulatory submission for daratumumab is now pending validation by the EMA and is based on data from the Phase 2 MMY2002 (SIRIUS) monotherapy study, which was presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO), data from the Phase 1/2 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). Ninety-five percent of patients in the study were double refractory to a PI and IMiD. Patients received three or more lines of prior therapy (median of five), including a PI and an IMiD. Daratumumab achieved an ORR of 29 percent 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. Patients enrolled in GEN501 received two or more lines of prior therapy (median four), including a PI and an IMiD, and 64 percent were refractory to both PIs and IMiDs. In this study, daratumumab demonstrated a tolerable safety profile and achieved an ORR of 36 percent (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 (95% CI: 4.2, 8.1) and 65 percent (95% CI: 28, 68) of responders remained in remission at 12 months. The OS rate at 12 months was 77 percent (95% CI: 58, 88).
