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In April 2016, the preliminary findings from the ongoing open-label, multi-center (Canada, Spain, and USA) phase 2 trial for daratumumab (SIRIUS) were published in The Lancet. This trial, led by Sagar Lonial from the Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, USA, assessed the efficacy of a novel anti-CD138 targeted antibody as a monotherapy in patients with refractory Multiple Myeloma (MM).
Daratumumab gave an ORR of 29% and was well tolerated at 16 mg/kg with a durable response. It, therefore, shows promise as a monotherapy in patients who are resistant to proteasome inhibitors and immunomodulatory drugs. Further studies to assess tolerability and efficacy in combination with other drug regimens are ongoing, and patients with early-stage MM (at the time of going to press) were being recruited to phase 3 trials. Daratumumab was the first monoclonal antibody approved for treatment of MM and is currently approved for therapy, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of treatment of patients with MM who have received at least one prior therapy.
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