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Updated results from a matching-adjusted indirect comparison of efficacy outcomes for ciltacabtagene autoleucel in CARTITUDE-1 versus idecabtagene vicleucel in KarMMa for the treatment of patients with relapsed or refractory multiple myeloma.
Martin, Tom; Usmani, Saad Z; Schecter, Jordan M; Roccia, Tito; Jackson, Carolyn C; Deraedt, William; Yeh, Tzu-Min; Banerjee, Arnob; Pacaud, Lida; Garrett, Ashraf; Bartlett, Meaghan; Haltner, Anja; Van Sanden, Suzy; Diels, Joris; Valluri, Satish; Samjoo, Imtiaz A.
Afiliação
  • Martin T; School of Medicine, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.
  • Usmani SZ; Department of Medicine, Levine Cancer Institute-Atrium Health, Charlotte, NC, USA.
  • Schecter JM; Janssen Global Services, Raritan, NJ, USA.
  • Roccia T; Janssen Global Services, Raritan, NJ, USA.
  • Jackson CC; Janssen Global Services, Raritan, NJ, USA.
  • Deraedt W; Janssen R&D, Beerse, Belgium.
  • Yeh TM; Janssen Global Services, Raritan, NJ, USA.
  • Banerjee A; Janssen R&D, Spring House, PA, USA.
  • Pacaud L; Legend Biotech USA, Inc, Piscataway, NJ, USA.
  • Garrett A; Legend Biotech USA, Inc, Piscataway, NJ, USA.
  • Bartlett M; EVERSANA, Burlington, Ontario, Canada.
  • Haltner A; EVERSANA, Chicago, IL, USA.
  • Van Sanden S; Janssen R&D, Beerse, Belgium.
  • Diels J; Janssen R&D, Beerse, Belgium.
  • Valluri S; Janssen Global Services, Raritan, NJ, USA.
  • Samjoo IA; EVERSANA, Burlington, Ontario, Canada.
Curr Med Res Opin ; 39(1): 81-89, 2023 01.
Article em En | MEDLINE | ID: mdl-36271807
OBJECTIVE: This study used the latest available data cuts from the CARTITUDE-1 and KarMMa clinical trials to update previously published matching-adjusted indirect treatment comparisons (MAICs) assessing the comparative efficacy of ciltacabtagene autoleucel (cilta-cel) versus the FDA-approved idecabtagene vicleucel (ide-cel) dose range of 300 to 450 × 106 CAR-positive T-cells in the treatment of patients with relapsed or refractory multiple myeloma (RRMM) who were previously treated with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody (i.e. triple-class exposed). METHODS: MAICs were performed with the latest available individual patient data for cilta-cel (CARTITUDE-1) and published summary-level data for ide-cel (KarMMa). The analyses included treated patients from CARTITUDE-1 who satisfied the eligibility criteria for KarMMa. The MAIC adjusted for unbalanced baseline covariates of prognostic significance identified in the literature and by clinical expertise. Comparative efficacy was assessed for overall response rate (ORR), complete response or better (≥CR) rate, duration of response (DoR), progression-free survival (PFS), and overall survival (OS). RESULTS: Cilta-cel was associated with statistically significantly improved ORR (odds ratio [OR]: 94.93 [95% confidence interval [CI]: 21.86, 412.25; p < .0001]; relative risk [RR]: 1.34), ≥CR rate (OR: 5.65 [95% CI: 2.51, 12.69; p < .0001]; RR: 2.23), DoR (hazard ratio [HR]: 0.52 [95% CI: 0.30, 0.88; p = .0152]), PFS, (HR: 0.38 [95% CI: 0.24, 0.62; p < .0001]), and OS (HR: 0.43 [95% CI: 0.22, 0.88; p = .0200]) compared with ide-cel. CONCLUSIONS: These analyses demonstrate improved efficacy with cilta-cel versus ide-cel for all outcomes over longer follow-up and highlight its therapeutic potential in triple-class exposed RRMM patients.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Mieloma Múltiplo / Antineoplásicos Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Mieloma Múltiplo / Antineoplásicos Idioma: En Ano de publicação: 2023 Tipo de documento: Article