ASCO 2019: Adding Daratumumab to Standard of Care in Transplant-Eligible Newly Diagnosed Myeloma
Posted: Thursday, June 13, 2019
The addition of the monoclonal antibody daratumumab to the triplet standard-of-care regimen of bortezomib/thalidomide/dexamethasone (VTd) prior to and as consolidation therapy after autologous stem cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma appears to improve patient outcomes, according to Philippe Moreau, MD, of the University Hospital Hôtel-Dieu, Nantes, France, and colleagues. Their study demonstrated an improvement in the depth of response and progression-free survival with the addition of daratumumab to VTd compared with VTd alone. The primary and final analysis of Part 1 of the CASSIOPEIA trial was presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract 8003). Based on these results, the U.S Food and Drug Administration (FDA) granted Priority Review for the use of daratumumab in combination with VTd in this patient population.
In this phase III study, 1,085 patients with transplant-eligible newly diagnosed multiple myeloma were randomly assigned to VTd (n = 542) or VTd plus daratumumab (n = 543) for induction and post-transplant consolidation therapy. All patients also received high-dose melphalan prior to ASCT.
At day 100 after transplant, the addition of daratumumab to VTd significantly increased the rate of postconsolidation stringent complete response compared with VTd alone (28.9% vs. 20.3%, P = .001). There was also a significant improvement in complete response associated with daratumumab (38.9% vs. 26%; P < .0001). The 18-month progression-free survival rates were 92.7% versus 84.6%, respectively.
The investigators reported “acceptable” safety with daratumumab plus VTd. The most common grade 3 or 4 treatment-emergent adverse events with the daratumumab combination therapy were neutropenia (27.6% vs. 14.7%), lymphopenia (17.0% vs. 9.7%), stomatitis (12.7% vs. 16.4%), and thrombocytopenia (11.0% vs. 7.4%). In the daratumumab arm, 35.4% of patients experienced an infusion-related reaction.
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.
