In an interim analysis of the international Phase 3 KarMMa-3 trial, patients with relapsed and refractory multiple myeloma who were treated with the B-cell maturation antigen–directed CAR T-cell therapy idecabtagene vicleucel (ide-cel) had significantly longer progression-free survival (PFS), with a 51% lower risk of disease progression or death, compared with patients who were treated with one of five standard regimens.
“The efficacy of ide-cel therapy was striking considering that 65% of patients had triple-class–refractory disease in a short time from diagnosis (4 years), with disease relapse at a median of approximately 7 months during the last previous regimen,” senior author Sergio Giralt, MD, of Memorial Sloan Kettering Cancer Center and colleagues reported in the New England Journal of Medicine in February.
A total of 386 patients who had previously received two to four treatment regimens were randomized in a 2:1 ratio to ide-cel or a standard regimen. After a median follow-up of 18.6 months, median PFS was 13.3 months in the ide-cel group and 4.4 months in the standard-regimen group. Patients treated with ide-cel experienced longer and deeper responses; 71% achieved a response and 39% a complete response, compared with 42% and 5%, respectively, in the standard-regimen group. Ide-cel toxicity was consistent with that seen in previous studies, with Grade 3 or higher cytokine release syndrome reported in 5% and Grade 3 or higher neurotoxicity in 3%.
“These findings provide potential support for the use of ide-cel in patients with triple-class–exposed relapsed and refractory multiple myeloma, a population with poor survival outcomes,” the authors conclude.
- Rodriguez-Otero P, Ailawadhi S, Arnulf B, et al. Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2023;388(11):1002-1014. doi:10.1056/NEJMoa2213614