Is Isatuximab Plus Carfilzomib/Dexamethasone the New Standard of Care in Relapsed Multiple Myeloma?
Posted: Wednesday, September 29, 2021
According to research presented in The Lancet, carfilzomib/dexamethasone plus isatuximab resulted in significantly improved survival and clinical outcomes in patients with relapsed multiple myeloma. Thomas Martin, MD, of the University of California, San Francisco, and colleagues sought to determine whether carfilzomib/dexamethasone regimens that include the anti-CD38 monoclonal antibody may outperform those that do not.
The phase III study was held at 69 centers across 16 countries between November 15, 2017, and March 21, 2019. A total of 302 patients with relapsed or refractory multiple myeloma who had received between one and three previous lines of therapy were enrolled and randomly assigned to either the isatuximab group (n = 179) or the control group (n = 123). All patients received carfilzomib/dexamethasone; those not in the control group also received intravenous isatuximab at 10 mg/kg weekly for 4 weeks and then every other week.
Patients in the isatuximab group experienced longer progression-free survival and superior depth of response. Median progression-free survival was not reached in the isatuximab group versus 19.15 months in the control group. Complete response was achieved by 40% of those who received isatuximab (n = 71) versus 28% (n = 34) of those who did not. The measurable residual disease negativity rate was more than double in the isatuximab group (30% vs. 13%).
However, treatment-emergent adverse events of at least grade 3 were more common with isatuximab (77% vs. 67%). The occurrence of serious treatment-related adverse events was comparable across groups (59% vs. 57%). Fewer patients in the isatuximab group discontinued treatment due to these adverse events (8% vs. 14%).
“Taken together, these results show that isatuximab plus carfilzomib/dexamethasone is a new standard of care for patients with relapsed multiple myeloma,” concluded the authors.
Disclosure: For full disclosures of the study authors, visit thelancet.com.