PMID- 35846215
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230916
IS  - 2688-6146 (Electronic)
IS  - 2688-6146 (Linking)
VI  - 3
IP  - 1
DP  - 2022 Feb
TI  - 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.
PG  - 97-108
LID - 10.1002/jha2.312 [doi]
AB  - INTRODUCTION: 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. METHODS: 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. RESULTS: 
      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; p < 0.0001]), TTNT (HR: 0.15 [95% CI: 0.09, 0.22; p < 0.0001]), and 
      OS (HR: 0.25 [95% CI: 0.13, 0.46; p < 0.0001]) versus PCT. Cilta-cel treatment 
      benefit was robust and consistent across all sensitivity analyses. CONCLUSION: 
      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.
CI  - (c) 2021 The Authors. eJHaem published by British Society for Haematology and John 
      Wiley & Sons Ltd.
FAU - Martin, Thomas
AU  - Martin T
AD  - UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California 
      USA.
FAU - Krishnan, Amrita
AU  - Krishnan A
AD  - Judy and Bernard Briskin Center for Multiple Myeloma Research Duarte California 
      USA.
FAU - Yong, Kwee
AU  - Yong K
AD  - University College Hospital London UK.
FAU - Weisel, Katja
AU  - Weisel K
AD  - University Medical Center Hamburg-Eppendorf Hamburg Germany.
FAU - Mehra, Maneesha
AU  - Mehra M
AD  - Janssen Global Services LLC Raritan New Jersey USA.
FAU - Nair, Sandhya
AU  - Nair S
AD  - Janssen Pharmaceutica NV Beerse Belgium.
FAU - Qi, Keqin
AU  - Qi K
AD  - Janssen R&D LLC Titusville New Jersey USA.
FAU - Londhe, Anil
AU  - Londhe A
AD  - Janssen R&D LLC Titusville New Jersey USA.
FAU - Diels, Joris
AU  - Diels J
AD  - Janssen Pharmaceutica NV Beerse Belgium.
FAU - Crivera, Concetta
AU  - Crivera C
AD  - Janssen Scientific Affairs LLC Horsham Pennsylvania USA.
FAU - Jackson, Carolyn C
AU  - Jackson CC
AD  - Levine Cancer Institute-Atrium Health Charlotte North Carolina USA.
FAU - Olyslager, Yunsi
AU  - Olyslager Y
AD  - Janssen Pharmaceutica NV Beerse Belgium.
FAU - Vogel, Martin
AU  - Vogel M
AD  - Janssen Global Services LLC Raritan New Jersey USA.
FAU - Schecter, Jordan M
AU  - Schecter JM
AD  - Janssen R&D Raritan New Jersey USA.
FAU - Banerjee, Arnob
AU  - Banerjee A
AD  - Janssen R&D Raritan New Jersey USA.
FAU - Valluri, Satish
AU  - Valluri S
AUID- ORCID: 0000-0001-9588-7238
AD  - Janssen Global Services LLC Raritan New Jersey USA.
FAU - Usmani, Saad Z
AU  - Usmani SZ
AD  - Levine Cancer Institute-Atrium Health Charlotte North Carolina USA.
FAU - Berdeja, Jesus G
AU  - Berdeja JG
AD  - Sarah Cannon Research Institute Nashville Tennessee USA.
FAU - Jagannath, Sundar
AU  - Jagannath S
AD  - Mount Sinai Medical Center New York New York USA.
LA  - eng
PT  - Journal Article
DEP - 20211210
PL  - United States
TA  - EJHaem
JT  - EJHaem
JID - 101761942
PMC - PMC9175662
OTO - NOTNLM
OT  - CARTITUDE-1
OT  - Flatiron Health
OT  - ciltacabtagene autoleucel
OT  - indirect treatment comparison
OT  - relapsed or refractory multiple myeloma
OT  - triple-class exposed
COIS- 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.
EDAT- 2022/07/19 06:00
MHDA- 2022/07/19 06:01
PMCR- 2021/12/10
CRDT- 2022/07/18 03:59
PHST- 2021/07/28 00:00 [received]
PHST- 2021/09/20 00:00 [revised]
PHST- 2021/09/21 00:00 [accepted]
PHST- 2022/07/18 03:59 [entrez]
PHST- 2022/07/19 06:00 [pubmed]
PHST- 2022/07/19 06:01 [medline]
PHST- 2021/12/10 00:00 [pmc-release]
AID - JHA2312 [pii]
AID - 10.1002/jha2.312 [doi]
PST - epublish
SO  - EJHaem. 2021 Dec 10;3(1):97-108. doi: 10.1002/jha2.312. eCollection 2022 Feb.