Posted: Friday, March 17, 2023
Findings from the phase III KarMMa-3 clinical trial, published in The New England Journal of Medicine, revealed that the B-cell maturation antigen–directed chimeric antigen receptor T-cell therapy idecabtagene vicleucel reduced the risk of disease progression and improved response in patients with resistant multiple myeloma. Sergio Giralt, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues compared idecabtagene vicleucel with standard regimens in patients with relapsed and refractory multiple myeloma who had received two to four lines of treatment.
“[These results]…clearly demonstrate the benefit of earlier use of a CAR T-cell therapy in providing the longest progression-free survival for patients with relapsed and refractory multiple myeloma compared to current standard regimens for these patients,” said coauthor Paula Rodriguez-Otero, MD, PhD, in a press release.
A total of 386 patients were randomly assigned in a 2:1 ratio to receive idecabtagene vicleucel (n = 254) or the standard regimen (n = 132). Patients received a single infusion of idecabtagene vicleucel (dose range, 150 × 106 to 450 × 106 CAR-positive T cells) or one of five different standard treatment regimens.
Overall findings revealed the median progression-free survival was 13.3 months with idecabtagene vicleucel and 4.4 months with standard treatment (hazard ratio for disease progression or death = 0.49; 95% confidence interval = 0.38 to 0.65; P < .001). Additionally, a response occurred in 71% of the idecabtagene vicleucel group and in 42% of the standard-regimen group (P < .001). Adverse events of grade 3 or 4 occurred in 93% of the patients in the idecabtagene vicleucel group and in 75% of those in the standard-regimen group.
“These findings provide potential support for the use of idecabtagene vicleucel in patients with triple-class–exposed relapsed and refractory multiple myeloma, a population with poor survival outcomes,” concluded the investigators.
Disclosure: For full disclosures of the study authors, visit nejm.org.
The New England Journal of Medicine