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Real-world data on the safety and efficacy of cilta-cel in patients with RRMM
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Cilta-cel, a BCMA targeting CAR T-cell therapy, was approved by the EMA and the U.S. FDA in 2022 for patients with RRMM exposed to ≥3 and ≥4 prior lines of therapy, respectively.1 These approvals were based on results from the phase Ib/II CARTITUDE-1 trial (NCT03548207).1 The Multiple Myeloma Hub previously reported the interim and the final results from this trial. Briefly, ORR and sCR rates were 98% and 83%, respectively, and median PFS and OS were 34.9 months and not reached, respectively.1 A multicenter, retrospective analysis including 16 medical centers in the U.S. Multiple Myeloma Immunotherapy Consortium assessed the safety and efficacy of cita-cel in a real-world population of 236 patients with RRMM in the SOC setting.1 Results from this analysis were published in Blood by Sidana et al.1 |
| Key learnings |
| Despite 54% of the infused patients not meeting the eligibility criteria of the CARTITUDE-1 trial, cilta-cel therapy demonstrated high response rates, with an ORR and ≥CR rate of 89% and 70%, respectively. |
| After a median follow-up of 13 months from infusion, median PFS and OS was not reached, with a 12-month estimated PFS and OS rate of 68% and 82%, respectively. High baseline ferritin levels, high-risk cytogenetics, and EMD were associated with inferior survival outcomes. |
| CRS, ICANS, and DNT occurred in 75% (Grade ≥3, 5%), 14% (Grade ≥3, 4%), and 10% of patients, respectively. |
| With the exception of non-melanoma skin cancers, 5.5% of patients had SPMs; 1.3% of which were myeloid malignancies or acute leukemias. |
| These findings demonstrate the efficacy of cilta-cel in a heterogenous real-world population of patients with RRMM. Additionally, the results highlight the need for close monitoring to mitigate late complications and avoid neurotoxicity. |
Abbreviations: BCMA, B-cell maturation antigen; CAR, chimeric antigen receptor; cita-cel, ciltacabtagene autoleucel; CR, complete response; CRS, cytokine release syndrome; DNT, delayed neurotoxicity; EMA, European Medicines Agency; EMD, extramedullary disease; FDA, Food and Drug Administration; ICANS, immune effector cell-associated neurotoxicity syndrome; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; RRMM, relapsed/refractory multiple myeloma; sCR, stringent CR; SOC, standard of care; SPM, second primary malignancy.
- Sidana S, Patel KK, Peres LC, et al. Safety and efficacy of standard of care ciltacabtagene autoleucel for relapsed/refractory multiple myeloma. Blood. 2024. Online ahead of print. DOI: 1182/blood.2024025945
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