Date: 2016-11-10
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Amgen (USA - CA) Janssen Biotech, a J&J company (USA - NJ)
Product: daratumumab, carfilzomib and dexamethasone
Action
mechanism: proteasome inhibitor/monoclonal antibody. Carfilzomib belongs to the class of proteasome inhibitors. Proteasome inhibitors block the proteasome, a system in cells that breaks down proteins when they are no longer needed. When proteins in the cancer cells are not broken down by the proteasome, the cells eventually die, slowing down the growth of the cancer. Carfilzomib is the first irreversible, highly-selective, proteasome inhibitor for multiple myeloma. The irreversible binding to the targeted proteasome leads to a more sustained inhibition with minimal inhibition of other non-targeted enzymes. Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma. It targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells and may also have potential in other cancers on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma. In May, 2013, daratumumab has been granted Breakthrough Therapy Designation from the FDA for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD. In August 2012, Genmab granted Janssen Biotech, an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
Disease: patients with multiple myeloma who have received one to three prior therapies
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On November 10, 2016, Genmab announced that daratumumab (Darzalex®) will be investigated in a Phase III clinical study in combination with carfilzomib (Kyprolis®) and dexamethasone in patients with relapsed/refractory multiple myeloma. The study will be conducted under a master clinical trial collaboration and supply agreement between Genmab's licensing partner for daratumumab, Janssen Biotech and Onyx Pharmaceuticals, a wholly-owned subsidiary of Amgen. The agreement covers all potential opportunities for combining daratumumab and carfilzomib (a proteasome inhibitor) for the treatment of patients with cancer.
The first study under this collaboration agreement will be a 450 patient Phase III, randomized, open-label, registration study that will seek to determine if daratumumab in combination with carfilzomib (56 mg/m2 twice weekly) and dexamethasone improves progression-free survival (PFS), compared to carfilzomib and dexamethasone alone in patients with multiple myeloma who have received one to three prior therapies. The study is anticipated to start dosing patients in 2017 and will be sponsored by Amgen.
