EHA24 Congress: Daratumumab Plus Standard Therapy in Newly Diagnosed Myeloma
Posted: Thursday, June 20, 2019
The clinical benefit of adding the CD38 monoclonal antibody daratumumab to the standard of care in transplant-eligible, newly diagnosed patients with multiple myeloma has been demonstrated in phase III study results for the first time, according to research presented by Philippe Moreau, MD, of University Hospital, Hôtel-Dieu Nantes, France, and colleagues at the 24th European Hematology Association (EHA24) Congress in Amsterdam (Abstract S145) and published in The Lancet. The study, CASSIOPEIA, involved more than 1,000 patients across Europe between the ages of 18 and 65.
The trial included 543 patients randomly assigned to receive bortezomib, thalidomide, and dexamethasone (VTd), the care standard, plus daratumumab. The control arm of 542 patients received VTd alone. In both cohorts, patients were treated with VTd in six 28-day cycles, four before autologous stem cell transplantation (ASCT) and two after.
“The primary endpoint was the rate of postconsolidation stringent complete response assessed at day 100 post-ASCT,” the investigators noted. It was clearly met, with the stringent complete response rate at day 100 significantly higher in the daratumumab arm than in the control arm (28.9% vs. 20.3%; P = .001). Furthermore, the 18-month progression-free survival rate was 92.7% versus 84.6% in the respective arms. “Rates of at least complete response, at least very good partial response, and minimal residual disease negativity supported stringent complete response results,” Dr. Moreau and his team also noted.
“D-VTd before and after autologous stem cell transplantation improved [the] depth of response and progression-free survival with acceptable safety,” the investigators concluded. Part 2 of the study, which is evaluating maintenance therapy, is ongoing.
Disclosure: The study authors’ disclosure information may be found at ehaweb.org.
