PracticeUpdate Conference Series - Ash 2017

Consistently Strong Results Support the Addition of Daratumumab to Therapy for Transplant-Ineligible Newly Diagnosed Myeloma

The combination of daratumumab with bortezomib, melphalan, and prednisone (VMP) in transplant ineligible patients with newly diagnosed multiple myeloma doubled progression-free survival (HR 0.50), driven by more patients achieving deep responses, including significantly higher complete response rate and tripling of the rate of negativity for minimal residual disease, outcome of the phase III, randomized ALCYONE study shows. M aria-Victoria Mateos, MD, of the University Hospital of Salamanca/Instituto de Investigación Biomédica de Salamanca, Daratumumab, a human immunoglobulin Gκ anti-CD38 monoclonal antibody with a direct on-tumor and multifaceted immunomodulatory mechanism of action, improves progression-free survival and depth of response significantly in com- bination with standard of care in relapsed multiple myeloma.

Spain, explained that VMP is a standard of care for transplant-ineligible newly diagnosed multiple myeloma. “The first phase I/II study,” Dr. Mateos told Elsevier’s PracticeUpdate , “that combined bortezomib + mel- phalan + prednisone was in Spain in 2004. Since then, we have been working to improve on this scheme to afford maximum patient benefit.” “Initially,” she continued, “bortezomib was given twice weekly, but peripheral neuropathy ensured. So, we proceeded to administer bortezomib once weekly. Weekly administration proved equally safe and effective as twice-weekly administration.” “The present study,” she explained, “completes this experience of VMP + the monoclonal antibody daratumumab. It has become the first randomized phase III study of daratumumab + VMP, the stand- ard of care, in newly diagnosed multiple myeloma.”

Treatment-naïve patients may benefit greatly with the addition of daratumumab to standard of care regimens. Dr. Mateos reported results of the ALCYONE study, where daratumumab is added to VMP in transplant-ineligible newly diagnosed multiple myeloma. Patients ≥65 years of age or otherwise ineligible for high-dose chemotherapy with autologous stem cell transplantation were randomized 1:1 to VMP ± daratumumab and stratified by International Staging System I, II, or III; region (Europe vs other); and age (<75 vs ≥75 years). Patients were randomized 1:1 to either nine 6-week cycles of VMP followed by observation or the same VMP scheme + daratumumab given as continuous therapy until disease progression:

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