EHA25 Virtual: Adding Isatuximab to Carfilzomib and Dexamethasone in Resistant Myeloma
Posted: Friday, June 19, 2020
The addition of the monoclonal-antibody isatuximab to a regimen of carfilzomib and dexamethasone resulted in a significant improvement in progression-free survival, with a manageable safety profile, in patients with resistant multiple myeloma. Philippe Moreau, MD, of the University Hospital Nantes, France, and colleagues presented these findings of this phase III trial in the virtual edition of the 25th European Hematology Association Annual Congress (EHA25 Virtual; Abstract LB2603).
The open-label study recruited 302 patients with relapsed or refractory multiple myeloma who were randomly assigned to receive carfilzomib and dexamethasone with or without intravenous isatuximab. More than three-quarters of patients had received either one or two prior lines of therapy. Proteasome inhibitors were used as a previous therapy in 90% of patients.
After a median follow-up of 20.7 months, the median progression-free survival was not yet reached with isatuximab, whereas it was 19.15 months with carfilzomib and dexamethasone alone (hazard ratio = 0.531). This benefit in progression-free survival was seen across all subgroups. The overall response rate was 86.6% in the isatuximab group compared with 82.9% in the control group. Complete responses were seen in 39.7% and 27.6% of the triple- and double-therapy groups, respectively. At the time of the presentation, 52% of patients receiving the isatuximab regimen are still on therapy, whereas 31% of patients receiving carfilzomib plus dexamethasone alone remain on treatment.
The most common reasons for treatment discontinuation were disease progression (29.1% with isatuximab vs. 39.8% without) and adverse events (8.4% vs. 13.8%). Adverse events graded 3 or higher were seen in 76.8% of patients in the triple-therapy group and 67.2% in the dual-therapy group. Such adverse events included respiratory infections, cardiac failure, thrombocytopenia, and neutropenia. Infusion reactions occurred in 45.8% of the isatuximab/carfilzomib/dexamethasone group and in 3.3% of the carfilzomib/dexamethasone group.
Disclosure: For full disclosures of study authors, visit library.ehaweb.org.
