Citations 1
Safety and efficacy of standard-of-care ciltacabtagene autoleucel for relapsed/refractory multiple myeloma
Sidana, Surbhi , Patel, Krina K. , Peres, Lauren C. , Bansal, Radhika , Kocoglu, Mehmet H. , Shune, Leyla , Atrash, Shebli , Smith, Kinaya, Midha, Shonali , Ferreri, Christopher J. , Dhakal, Binod , Wagner, Charlotte B , Hosoya, Hitomi , Mikkilineni, Lekha , Atanackovic, Djordje , Mann, Hashim , Kalariya, Nilesh, Hovanky, Vanna, DeAvila, Gabriel, Freeman, Ciara L. , Alsina, Melissa , Wong, Sandy W. , Htut, Myo , Sborov, Douglas W. , Khouri, Jack , Janakiram, Murali , Lin, Yi, Dima, Danai , Wagner, Charlotte , Atanackovic, Djordje , Chhabra, Saurabh , Parrondo, Ricardo D , Mann, Hashim , Freeman, Ciara L , Herr, Megan M. , McGuirk, Joseph , Sborov, Douglas W , Khouri, Jack , Sidana, Surbhi , Kocoglu, Mehmet H , Patel, Krina , Atrash, Shebli , Hosoya, Hitomi , Janakiram, Murali , Dhakal, Binod , Dima, Danai , Costello, Patrick , Reshef, Ran , Chhabra, Saurabh , Nadeem, Omar , Locke, Frederick L. , McGuirk, Joseph P. , Martin, Thomas , Hansen, Doris K.
Blood | October 4, 2024 | Volume: 145 | Issue: 1 | Pages: 85-97
Abstract Ciltacabtagene autoleucel (cilta-cel) was approved in 2022 for patients with relapsed/refractory multiple myeloma (RRMM). We report outcomes with cilta-cel in the standard-of-care setting. Patients with RRMM who underwent leukapheresis for cilta-cel manufacturing between 1 March 2022 and 31 December 2022 at 16 US academic medical centers were included. Overall, 255 patients underwent leukapheresis and 236 (92.5%) received cilta-cel, of which 54% would not have met CARTITUDE-1 eligibility criteria. In treated patients (N = 236), cytokine release syndrome was seen in 75% (grade ≥3, 5%), immune effector cell–associated neurotoxicity syndrome in 14% (grade ≥3, 4%), and delayed neurotoxicity in 10%. Overall and complete response rates were as follows: all patients who received cilta-cel (N = 236), 89% and 70%; patients receiving conforming cilta-cel (n = 191), 94% and 74%; and conforming cilta-cel with fludarabine/cyclophosphamide lymphodepletion (n = 152), 95% and 76%, respectively. Nonrelapse mortality was 10%, most commonly from infection. After a median follow-up of 13 months from cilta-cel, the median progression-free survival (PFS) was not reached, with 12-month estimate being 68% (95% confidence interval, 62-74). High ferritin levels, high-risk cytogenetics, and extramedullary disease were independently associated with inferior PFS, with a signal for prior B-cell maturation antigen–targeted therapy (P = .08). Second primary malignancies excluding nonmelanoma skin cancers were seen in 5.5% and myeloid malignancies/acute leukemia in 1.7%. We observed a favorable efficacy profile of standard-of-care cilta-cel in RRMM, despite more than half the patients not meeting the CARTITUDE-1 eligibility criteria.