MM logo

Cilta-cel Provides HRQOL Benefit in Patients with Triple-Class Exposed MM

CARTITUDE-1 is an ongoing, phase 1b/2, open-label, multicenter study which evaluates ciltacabtagene autoleucel (cilta-cel) for the treatment of patients with relapsed/refractory multiple myeloma (RRMM), whereas LocoMMotion is a study of real-world clinical practice (RWCP) in patients with RRMM who received ≥3 prior lines of therapy, including proteasome inhibitor, immunomodulatory drug, and CD38 monoclonal antibody treatment. Adjusted comparisons of these 2 studies have shown response and survival benefit of cilta-cel in patients with triple-class exposed multiple myeloma (TCE-MM); however, it is known that the health-related quality of life (HRQOL) in these patients is reduced compared with age- and sex-matched populations. At the 2022 International Myeloma Society meeting, Mateos and colleagues presented adjusted comparisons of patient-reported outcomes (PROs) from TCE-MM patients treated with cilta-cel in the CARTITUDE-1 study and in RWCP, as measured in LocoMMotion.

Researchers administered the EuroQol 5 dimensions (EQ-5D-5L); the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire; and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, myeloma-specific module to all patients at baseline, day 7, day 28, and every 4 weeks up to a year. Researchers expected the PRO benefit with cilta-cel to be underestimated because cilta-cel demonstrated superior progression-free survival and overall survival compared with RWCP, and assessments were only available before progression. A responder analysis was performed for each PRO to adjust for this selection bias, which estimated by time point the percentage of patients still progression-free with clinically meaningful improvement, worsening, or no change, and the percentage of patients who progressed and died.

In total, 61 patients in CARTITUDE-1 and 202 patients in LocoMMotion completed PRO assessments at baseline and follow-up. Compared with baseline, PRO scores among patients in both cohorts decreased by day 7. Patients experienced short-term adverse events such as fatigue, lack of appetite, and constipation, which are associated with cilta-cel infusion and lymphodepleting chemotherapy. After week 4, however, PROs significantly improved from baseline over time with cilta-cel use, whereas improvement from baseline for RWCP patients was lower for most symptoms and domains. Significantly better outcomes were seen with cilta-cel versus RWCP for visual analog scale, global health status, pain, dyspnea, constipation, future perspective, emotional functioning, and feeling restless or agitated. In the responder analysis, the percentage of patients reaching clinically meaningful improvement was greater for cilta-cel: EQ-5D-5L visual analog scale (36.6% vs 10.8%), global health score (31.4% vs 10.8%), physical functioning (29.3% vs 8.7%), role functioning (27.2% vs 8.7%), social functioning (23.0% vs 8.7%), cognitive functioning (20.9% vs 2.2%), emotional functioning (23.0% vs 4.3%), dyspnea (10.5% vs 0%), and future perspective (43.1% vs 7.4%; P <.01 for all).

Researchers concluded that cilta-cel significantly improved HRQOL, in addition to its efficacy benefits, in patients with TCE-MM and showed favorable improvement in PRO scores compared with RWCP across preselected end points.

Source:

Mateos MV, Weisel K, Vincent L, et al. Ciltacabtagene autoleucel (cilta-cel) versus real world clinical practice in triple-class exposed multiple myeloma: adjusted comparison of patient reported outcomes from CARTITUDE-1 and LocoMMotion. Poster presented at: International Myeloma Foundation; August 25-27, 2022; Los Angeles, CA.

Related Articles

Subscribe Today!

To sign up for our free e-Newsletter or print publications, please enter your contact information below.

I'd like to receive:

OPM e-Newsletter
OPM print publication