Daratumumab: A Review in Combination Therapy for Transplant-Ineligible Newly Diagnosed Multiple Myeloma
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ADIS DRUG EVALUATION
Daratumumab: A Review in Combination Therapy for Transplant‑Ineligible Newly Diagnosed Multiple Myeloma Yahiya Y. Syed1
© Springer Nature Switzerland AG 2019
Abstract Intravenous daratumumab ( DARZALEX®) is a human CD38 monoclonal antibody approved as combination therapy (with bortezomib, melphalan and prednisone) for patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (ASCT). The approval was based on results of the phase 3 ALCYONE trial in which the addition of daratumumab to bortezomib, melphalan and prednisone significantly prolonged median progression-free survival (PFS) relative to bortezomib, melphalan and prednisone alone (primary endpoint). Daratumumab addition was also associated with deeper and durable responses relative to the comparator. The addition of daratumumab did not increase overall toxicity, with the exception of infusion-related reactions and increased rates of infections. The incidences of the most common grade 3 or 4 adverse events in the daratumumab group (neutropenia, thrombocytopenia and anaemia) were largely similar to those in the comparator group. Thus, daratumumab in combination with bortezomib, melphalan and prednisone represents a promising treatment option for patients with NDMM who are ineligible for ASCT.
Daratumumab: clinical considerations in transplant‑ineligible NDMM First-in-class CD38 monoclonal antibody Prolongs PFS, and induces deeper and durable responses, when combined with bortezomib, melphalan and prednisone Acceptable tolerability profile; does not increase overall toxicity of the combination, apart from infections and infusion-related reactions
The manuscript was reviewed by: N. Callander, University of Wisconsin Carbone Cancer Center, Madison, WI, USA; C. Cerchione, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy; S. A. Holstein, Internal Medicine, University of Nebraska Medical Center, Omaha, NE, USA; T. Ichinohe, Department of Haematology and Oncology, Hiroshima University, Hiroshima, Japan; S. Knop, Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany. * Yahiya Y. Syed [email protected] 1
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1 Introduction Multiple myeloma (MM) is a malignant neoplasm of plasma cells [1]. Although MM remains incurable, survival rates are steadily increasing due to the availability of new classes of drugs, such as proteasome inhibitors (bortezomib, carfilzomib, ixazomib), immunomodulatory drugs (thalidomide, lenalidomide, pomalidomide), histone deacetylase inhibitors (panobinostat) and monoclonal antibodies (daratumumab, elotuzumab), which are used with corticosteroids and chemotherapy in doublet, triplet or quadruplet combinations [1–3]. ASCT is an important component of the treatment plan for NDMM [1, 3, 4] and is associated with high response rates and improved PFS and overall survival (OS) [1, 5, 6]. However, ASCT is reserved for fit
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