| Autor: |
Mateos MV; University Hospital of Salamanca/IBSAL, CIC, Salamanca. mvmateos@usal.es., Weisel K; University Medical Center Hamburg-Eppendorf, Hamburg., Martin T; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA., Berdeja JG; Sarah Cannon Research Institute, Nashville, TN., Jakubowiak A; University of Chicago., Stewart AK; University Health Network and the Princess Margaret Cancer Centre, Toronto, ON., Jagannath S; Mount Sinai Medical Center., Lin Y; Mayo Clinic, Rochester, MN., Diels J; Janssen Pharmaceutica NV, Beerse., Ghilotti F; Janssen-Cilag SpA, Cologno Monzese., Thilakarathne P; Janssen Pharmaceutica NV, Beerse., Perualila NJ; Janssen Pharmaceutica NV, Beerse., Cabrieto J; Janssen Pharmaceutica NV, Beerse., Haefliger B; Cilag GmbH International, Zug., Erler-Yates N; Janssen-Cilag GmbH, Neuss., Hague C; Janssen-Cilag N.V., High Wycombe., Jackson CC; Janssen R-D, Raritan, NJ., Schecter JM; Janssen R-D, Raritan, NJ., Strulev V; EMEA Medical Affairs, Janssen Pharmaceutica NV, Beerse., Nesheiwat T; Legend Biotech USA Inc., Piscataway, NJ., Pacaud L; Legend Biotech USA Inc., Piscataway, NJ., Einsele H; UniversitätsklinikumWürzburg, Medizinische Klinik und Poliklinik II, Würzburg., Moreau P; ClinicalHematology, University Hospital Hotel-Dieu, Nantes. |
| Abstrakt: |
Ciltacabtagene autoleucel (cilta-cel) is a chimeric antigen receptor T-cell therapy studied in patients with multiple myeloma exposed to three classes of treatment in the single-arm CARTITUDE-1 study. To assess the effectiveness of cilta-cel compared to real-world clinical practice (RWCP), we performed adjusted comparisons using individual patients' data from CARTITUDE-1 and LocoMMotion, a prospective, multinational study of patients with multiple myeloma triple-class exposed of treatment. Comparisons were performed using inverse probability weighting. In CARTITUDE-1, 113 patients were enrolled, and 97 patients were infused with cilta-cel. In LocoMMotion, 248 patients were enrolled, and 170 patients were included in the comparisons versus infused patients. Ninety-two unique regimens were used in LocoMMotion, most frequently carfilzomib-dexamethasone (13.7%), pomalidomide-cyclophosphamide-dexamethasone (13.3%) and pomalidomidedexamethasone (11.3%). Adjusted comparisons showed that patients treated with cilta-cel were 3.12-fold more likely to respond to treatment than those managed by RWCP (response rate, 3.12, 95% confidence interval [95% CI]: 2.24-4.00), had their risk of progression or death reduced to by 85% (progression-free survival hazard ratio=0.15, 95% CI: 0.08-0.29), and a risk of death lowered by 80% (overall survival hazard ratio HR=0.20, 95% CI: 0.09-0.41). The incremental improvement in healthrelated quality of life from baseline for cilta-cel versus RWCP at week 52, as measured by EORTC QLQ-C30 Global Health Status, was 13.4 (95% CI: 3.5-23.6) and increased to 30.8 (95% CI: 21.8-39.8) when including death as additional information regarding patients' health status. Patients treated with cilta-cel experienced more adverse events than those managed with RWCP (any grade: 100% vs. 83.5%). The results from this study demonstrate improved efficacy outcomes of cilta-cel versus RWCP and highlight its potential as a novel and effective treatment option for patients with multiple myeloma triple-class exposed of antimyeloma treatment. CARTITUDE-1 is registered with clinicaltrials gov. Identifier: NCT03548207. LocoMMotion is registered with clinicaltrials gov. Identifier: NCT04035226. |
