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Daratumumab (dara) is a humanized monoclonal antibody that binds to CD38, a molecule found on the cell surface of the majority of multiple myeloma (MM) cells. Dara has been approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as a treatment for patients with relapsed and/or refractory (RR)MM either as a monotherapy or in combination with bortezomib (bor) and lenalidomide (len). In addition, dara has recently been approved by the FDA and EMA as a front-line treatment in combination with bor, melphalan, and prednisone for newly diagnosed (ND)MM patients.
In the POLLUX study, an on-going, phase III, multi-centered clinical trial, RRMM patients were randomized to receive either dara, in combination with len and low-dose dexamethasone (dex), or len with dex. Results from the first interim analysis of this study (13.5 months follow-up time) showed a significant reduction in disease progression or death in the dara/len/dex group compared to the len/dex group1.
The lead investigator of the POLLUX study, Meletios A. Dimopoulos from the Athens School of Medicine, Athens, Greece, and colleagues, continued to follow up on the PFS results. They also examined PFS among groups of patients with specific characteristics and have evaluated the impact of each treatment on the minimal residual disease (MRD). These updated results were published in Heamatologica in September 2018.
Results are presented as dara/len/dex vs len/dex.
The current update on the POLLUX study supports previously published results indicating superior PFS and ORR in patients with RRMM treated with dara/len/dex vs len/dex. In addition, the dara/len/dex combination results in a significantly improved MRD negativity compared to that observed in the len/dex group.
References
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