Comparative effectiveness of ciltacabtagene autoleucel in CARTITUDE-1 versus physician's choice of therapy in the Flatiron Health multiple myeloma cohort registry for the treatment of patients with relapsed or refractory multiple myeloma.

Ciltacabtagene autoleucel (cilta-cel) is a novel chimeric antigen receptor T-cell therapy that is being evaluated in the CARTITUDE-1 trial (NCT03548207) in patients with relapsed or refractory multiple myeloma (RRMM) who received as part of their previous therapy an immunomodulatory drug, proteasome inhibitor, and an anti-CD38 monoclonal antibody (i.e., triple-class exposed). Given the absence of a control arm in CARTITUDE-1, this study assessed the comparative effectiveness of cilta-cel and physician's choice of treatment (PCT) using an external real-world control arm from the Flatiron Health multiple myeloma cohort registry. Given the availability of individual patient data for cilta-cel from CARTITUDE-1 and PCT in Flatiron, inverse probability of treatment weighting was used to adjust for unbalanced baseline covariates of prognostic significance: refractory status, cytogenetic profile, International Staging System stage, time to progression on last regimen, number of prior lines of therapy, years since diagnosis, and age. Comparative effectiveness was estimated for progression-free survival (PFS), time to next treatment (TTNT), and overall survival (OS). A range of sensitivity analyses were conducted. Baseline characteristics were similar between the two cohorts after propensity score weighting. Patients with cilta-cel had improved PFS (HR: 0.18 [95% CI: 0.12, 0.27; Cilta-cel demonstrated significantly superior effectiveness over PCT for all outcomes, highlighting its potential as an effective therapy in patients with triple-class exposed RRMM.

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© 2021 The Authors. eJHaem published by British Society for Haematology and John Wiley & Sons Ltd.

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KW received honoraria from and served in a consulting or advisory role for Adaptive Biotechonlogies, Amgen, BMS, Celgene, GSK, Janssen, KaryopharmTherapeutics, Oncopeptides, Roche/Genentech, Sanofi, and Takeda, served in a consulting or advisory role for GSK, received travel funding from Amgen, BMS, Celgene, GSK, Janssen, and Takeda, and received research funding from Amgen, Celgene, Janssen, and Sanofi.TM served in a consulting or advisory role for GlaxoSmithKline and Juno Therapeutics, and received research funding from Amgen, Janssen, and Sanofi.AK served in a consulting or advisory role for Adaptive Biotechnologies, Celgene/Bristol Meyers‐Squibb, GlaxoSmithKline, Janssen Oncology, Pfizer, Regeneron, served on speakers bureaus for Amgen, Celgene/Bristol Meyers‐Squibb, GlaxoSmithKline and Takeda, served on scientific advisory boards for Sutro Biopharma, has equity in Celgene/Bristol Meyers‐Squibb, and received research funding from Janssen Oncology.SJ is a consultant for Bristol Myers Squibb, Janssen, Karyopharm Therapeutics, Merck, Sanofi, and Takeda Pharmaceuticals.SZU served in a consulting or advisory role for AbbVie, Amgen, Celgene, GlaxoSmithKline, Janssen, Karyopharm Therapeutics, Merck, Seattle Genetics, Skyline Diagnostics, and Takeda, served on speakers bureaus for Celgene, Janssen, Sanofi, and Takeda, and received research funding from Amgen, Array BioPharma, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Merck, Pharmacyclics, Sanofi, Seattle Genetics, and Skyline Diagnostics.JGB served in a consulting or advisory role for Bluebird Bio, Bristol Myers Squibb, Celgene, CRISPR Therapeutics, Janssen, Karyopharm Therapeutics, Kite/Gilead, Legend Biotech, Secura Bio, Servier, and Takeda, and received research funding from AbbVie, Acetylon Pharmaceuticals, Amgen, Bluebird Bio, Bristol Myers Squibb, Celgene, Celularity, Constellation Pharmaceuticals, CURIS, EMD Serono, Genentech/Roche, Glenmark, Ichnos Sciences, Janssen, Kesios Therapeutics, Lilly, Novartis, Poseida, Sanofi, Takeda, Teva, and Vivolux.KY is consultant physician and received honoraria from Janssen, GSK, Amgen Inc., Takeda, Sanofi and research funding from Janssen, Takeda, Sanofi.AL, CC, JMS, KQ, MV, AB, JD, SN, SV, and YO are employed by Janssen and have restricted stock units and/or stock options. CCJ is employed by Janssen and is a consultant physician at the Memorial Sloan Kettering Cancer Center. MM was employed by Janssen when the study was conducted.