FREEDOMM: Fifth-Line or Later Real-World Evaluation of Efficacy and Disease Outcomes in Multiple Myeloma with Ciltacabtagene Autoleucel: Treatment-Free Interval and Overall Survival in the USA.

INTRODUCTION

Ciltacabtagene autoleucel (cilta-cel) was approved in February 2022 for adults with relapsed/refractory multiple myeloma (RRMM). This study evaluated US real-world outcomes among patients with RRMM treated with cilta-cel after ≥ 4 prior lines of therapy (4 + pLOT), overall and stratified by receipt of bridging therapy (BT).

METHODS

Adults with RRMM receiving standard-of-care cilta-cel after 4 + pLOT were identified using claims data from the Komodo Research Database (01/01/2016-06/30/2024). Treatment-free interval (TFI; time between cilta-cel infusion and initiation of next treatment or death) and overall survival (OS) were evaluated using Kaplan-Meier (KM) analyses. Adjusted multivariate Cox regression was used to assess hazard ratios (HR) and 95% confidence intervals (CIs) for TFI/OS by receipt of BT.

RESULTS

Among 242 patients receiving cilta-cel (mean age 63.4 years, 45.5% were female patients, 54.5% were male patients), those with BT (75.2%) had a higher comorbidity burden (mean Quan-Charlson Comorbidity Index 5.3 vs. 4.7) and higher frailty index score (mild-to-severe 49.4% vs. 28.3%) than those without. The median follow-up was 11 months. Using KM methods to account for variable follow-up, the estimated TFI at 18 months post-infusion was 80.3%, while the KM estimate of OS at 18 months post-infusion was 93.4%. Median TFI or OS was not reached. Patients with BT were numerically less likely to have a TFI event (HR 0.76, 95% CI 0.32-1.80) and more likely to remain alive (HR 0.48, 95% CI 0.13-1.70) relative to those without BT.

CONCLUSION

Consistent with pivotal trials, cilta-cel was effective in patients with RRMM and 4 + pLOT in US clinical practice. Findings align with previous results supporting BT effectiveness. Graphical abstract available for this article.