Overall Survival With Daratumumab-Based Regimen in Myeloma
Posted: Wednesday, March 11, 2020
According to research presented at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida (Abstract 859) and published in the journal Blood, patients who had been newly diagnosed with multiple myeloma and were not eligible for transplantation experienced survival benefits with a combination treatment of daratumumab, bortezomib, melphalan, and prednisone. The findings come from extended follow-up of patients in the ALCYONE trial, which previously found the four-drug regimen improved 24-month progression-free survival and reduced the risk of disease progression.
“For the first time, we demonstrate that the addition of [daratumumab] to [bortezomib/melphalan/prednisone] prolongs [overall survival] in patients with transplant-ineligible [newly diagnosed multiple myeloma], with a 40% reduction in the risk of death versus [bortezomib/melphalan/prednisone] alone after a median follow-up of 40 months,” concluded Maria-Victoria Mateos, MD, PhD, of the University Hospital of Salamanca, Spain, and colleagues. “These findings, together with the phase III MAIA study ([daratumumab] plus lenalidomide/dexamethasone vs lenalidomide/dexamethasone), continue to support the addition of [daratumumab] to front-line treatment regimens in patients with transplant-ineligible [newly diagnosed multiple myeloma].”
The study included 706 patients with newly diagnosed multiple myeloma who were ineligible for transplantation and high-dose chemotherapy. The participants were randomly assigned to receive a maximum of nine 6-week cycles of bortezomib/melphalan/prednisone either alone (n = 356) or in addition to daratumumab (n = 350).
At a median follow-up of 40.08 months, median progression-free survival was 36.4 months for patients receiving daratumumab versus 19.3 months for those who were not. Within the daratumumab group, median progression-free survival on a subsequent line of therapy was not reached versus 42.3 months in the bortezomib/melphalan/prednisone group. In addition to these improved outcomes, the daratumumab group also had a higher estimated 36-month overall survival rate of 78% versus 68% in the other group. However, median overall survival was not reached for either group at the time of the presentation.
Disclosure: For full disclosures of the study authors, visit ashpublications.org.