Daratumumab to be studied in combination with carfilzomib in multiple myeloma

Continuing the trend in the cancer therapy sector of testing combination regimens, Danish biotech firm Genmab (OMX: GEN) has announced plans for its Darzalex (daratumumab) to be investigated in a Phase III trial as a treatment for relapsed/refractory multiple myeloma in combination with another drug.

The study will be conducted under a master clinical trial collaboration and supply agreement between Genmab’s licensing partner for daratumumab, Janssen Biotech, a subsidiary of US healthcare giant Johnson & Johnson (NYSE: JNJ), and Onyx Pharmaceuticals, a wholly-owned subsidiary of Amgen (Nasdaq: AMGN). The agreement covers all potential opportunities for combining daratumumab and carfilzomib (a proteasome inhibitor marketed by Amgen as Kyprolis) 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 trial 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.