The efficacy and safety outcomes associated with idecabtagene vicleucel (ide-cel) were similar in a real-world population of patients with relapsed/refractory multiple myeloma (RRMM) as observed in pivotal phase 2 trials, according to the results of a study published in the Journal of Clinical Oncology.
“The patient population differed from the pivotal KarMMa clinical trial as 75% of apheresed patients in our study would not have met trial eligibility criteria,” the authors wrote in their report.
This multicenter, retrospective study evaluated data from 159 patients with RRMM who underwent leukapheresis for ide-cel treatment. The median follow-up from infusion was 6.1 months.
The median age of the cohort was 64 and 57% of patients were male. There were 48% of patients with extramedullary disease and 25% had a high bone marrow burden. The majority of patients had an R-ISS disease stage of II or III, and high-risk cytogenetics were present among 35%. Nearly all patients had received prior treatment with a proteosome inhibitor and an anti-CD38 antibody. There were 89%, 84%, and 44% of patients who were double-, triple-, or penta-refractory. There were 21% of patients who received prior anti-BCMA treatment and 6% had received an allogeneic stem cell transplant.
The best overall response rate with ide-cel was 84%, with a complete response rate of 42%. The duration of response was 8.6 months. The duration of progression-free survival (PFS) was a median of 8.5 months and the median overall survival was 12.5 months.
Shorter PFS was significantly associated with prior exposure to a BCMA-targeted therapy, the presence of high-risk cytogenetics (hazard ratio [HR], 2.81; 95% CI, 1.44-5.51; P =.003), and an Eastern Cooperative Oncology Group performance status of 2 or higher at the time of lymphodepletion (HR, 2.19; 95% CI, 1.16-4.14; P =.02) in a multivariate analysis. There was no difference according to presence of extramedullary disease, performance status, prior lines of therapy, penta-refractory status, or chimeric antigen receptor T-cell dose.
The rate of any grade cytokine release syndrome was 82%, with 3% of patients developing grade 3 or higher severity. Neurotoxicity occurred among 18% of patients, with 6% grade 3 or higher.
The authors concluded that “the efficacy and safety profile with standard-of-care ide-cel is comparable to that observed in the KarMMa trial.” They added that “if BCMA chimeric antigen receptor T-cell treatment is planned, prior exposure to BCMA-targeted therapy should be avoided.”
Disclosures: Some of the study authors declared affiliations with biotech, pharmaceutical, or device companies. Please see the original reference for a full list of disclosures.
Hansen DK, Sidana S, Peres LC, et al. Idecabtagene vicleucel for relapsed/refractory multiple myeloma: real-world experience from the Myeloma CAR T Consortium. J Clin Oncol. Published online January 9, 2023. doi: 10.1200/JCO.22.01365