Idecabtagene Vicleucel Improves Health-Related Quality of Life Compared With Standard Therapeutic Regimens for Patients With R/R MM

Idecabtagene vicleucel, a chimeric antigen receptor (CAR) T-cell therapy, demonstrates improved health-related quality of life (QoL) compared with standard therapeutic regimens among patients with relapsed/refractory (R/R) multiple myeloma (MM) after previous lines of therapy, according to phase 3 data from the KarMMa-3 trial.

This randomized, open-label study included 386 hospitalized patients who were ≥18 years of age, with measurable disease and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, who had received 2 to 4 previous regimens—including an immunomodulatory agent, a proteasome inhibitor, and daratumumab—and had documented disease progression after receiving their last dose of the last therapy. Investigators randomly assigned 254 patients to receive idecabtagene vicleucel, and 132 patients to receive standard regiments (daratumumab, pomalidomide, and dexamethasone; daratumumab, bortezomib, and dexamethasone; ixazomib, lenalidomide, and dexamethasone; carfilzomib and dexamethasone; or elotuzumab, pomalidomide, and dexamethasone).

Trial participants also completed the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life C30 Questionnaire (QLQ-C30), Multiple Myeloma Module (QLQ-MY20), EQ 5 dimensions (EQ-5D), and EQ-5D visual analogue scale (VAS) at baseline and follow-up timepoints. Patient-reported outcomes included 9 prespecified primary domains: EORTC QLQ-C30 GHS–QoL, physical functioning, cognitive functioning, fatigue, and pain; QLQ-MY20 disease symptoms and side effects of treatment; and 5-level EQ-5D (EQ-5D-5L) index score and EQ-5D visual VAS.

Study results demonstrated, with a median follow-up of 18.6 months (interquartile range [IQR] 14 to 26.4), patient-reported outcome compliance was higher than 75% throughout. Patients in the idecabtagene vicleucel group showed statistically significant and clinically meaningful improvements across the primary patient-reported outcome domains of interest, with the exception of QLQ-MY20 disease symptoms, side effects of treatment, and EQ-5D-5L index score. This score showed improvement across assessment visits but did not exceed the within-group minimally important difference thresholds.

Additionally, it was noted that the idecabtagene vicleucel group had shorter times to clinically meaningful improvement than the standard regimens group in the QLQ-C30 domains except in role functioning, diarrhea, and financial difficulties; in the QLQ-MY20 domains except body image; and in EQ-5D-VAS.

Michel Delforge, MD, University Hospital Leuven, Leuven, Belgium, and colleagues concluded, Ide-cel offers improved health-related quality of life compared with standard regimens for patients with relapsed and refractory multiple myeloma after previous lines of therapy.”

“The [patient-reported outcome] data highlight the extended QoL benefits of a one-time infusion with [idecabtagene vicleucel] compared with continuous treatment with standard regimens in the treatment of triple-class exposed patients with relapsed and refractory multiple myeloma,” they added.

Source:

Delforge M, Patel K, Eliason L, et al. Health-related quality of life in patients with triple-class exposed relapsed and refractory multiple myeloma treated with idecabtagene vicleucel or standard regimens: Patient-reported outcomes from the phase 3, randomized, open-label KarMMa-3 clinical trial. Lancet Hematol, Volume 11, Issue 3; E216-E227. Published March, 2024. doi: 10.1016/S2352-3026(24)00005-X