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

被引:14
|
作者
Martin, Tom [1 ]
Usmani, Saad Z. [2 ]
Schecter, Jordan M. [3 ]
Roccia, Tito [3 ]
Jackson, Carolyn C. [3 ]
Deraedt, William [4 ]
Yeh, Tzu-Min [3 ]
Banerjee, Arnob [5 ]
Pacaud, Lida [6 ]
Garrett, Ashraf [6 ]
Bartlett, Meaghan [7 ]
Haltner, Anja [8 ]
Van Sanden, Suzy [4 ]
Diels, Joris [4 ]
Valluri, Satish [3 ]
Samjoo, Imtiaz A. [7 ]
机构
[1] UCSF Helen Diller Family Comprehens Canc Ctr, Sch Med, San Francisco, CA USA
[2] Levine Canc Inst Atrium Hlth, Dept Med, Charlotte, NC USA
[3] Janssen Global Serv, Raritan, NJ USA
[4] Janssen R&D, Beerse, Belgium
[5] Janssen R&D, Spring House, PA USA
[6] Legend Biotech USA Inc, Piscataway, NJ USA
[7] EVERSANA, 204-3228 South Serv Rd, Burlington, ON L7N 3H8, Canada
[8] EVERSANA, Chicago, IL USA
关键词
relapsed or refractory multiple myeloma; ciltacabtagene autoleucel; CARTITUDE-1; idecabtagene vicleucel; KarMMa; indirect treatment comparison; T-CELL THERAPY;
D O I
10.1080/03007995.2022.2139052
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 x 10(6) 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.
引用
收藏
页码:81 / 89
页数:9
相关论文
共 50 条
  • [41] Efficacy Outcomes and Characteristics of Patients with Multiple Myeloma (MM) Who Achieved Sustained Minimal Residual Disease Negativity after Treatment with Ciltacabtagene Autoleucel (cilta-cel) in CARTITUDE-1
    Munshi, Nikhil C.
    Paiva, Bruno
    Martin, Thomas
    Usmani, Saad
    Lin, Yi
    Schecter, Jordan M.
    Jackson, Carolyn C.
    Madduri, Deepu
    Zudaire, Enrique
    Yeh, Tzu-min
    Bartlett, J. Blake
    Pacaud, Lida
    Akram, Muhammad
    Geng, Dong
    Jagannath, Sundar
    Cohen, Adam D.
    San-Miguel, Jesus
    BLOOD, 2022, 140 : 4652 - 4654
  • [42] A Matching-Adjusted Indirect Comparison of the Efficacy of Elranatamab Versus Physician's Choice of Treatment in Patients with Triple-Class Exposed/Refractory Multiple Myeloma
    Mol, Isha
    Hu, Yannan
    LeBlanc, Thomas W.
    Cappelleri, Joseph C.
    Chu, Haitao
    Nador, Guido
    Aydin, Didem
    Schepart, Alex
    Hlavacek, Patrick
    BLOOD, 2023, 142
  • [43] A matching-adjusted indirect comparison of the efficacy of elranatamab versus physician's choice of treatment in patients with triple-class exposed/refractory multiple myeloma
    Mol, Isha
    Hu, Yannan
    Leblanc, Thomas W.
    Cappelleri, Joseph C.
    Chu, Haitao
    Nador, Guido
    Aydin, Didem
    Schepart, Alex
    Hlavacek, Patrick
    CURRENT MEDICAL RESEARCH AND OPINION, 2024, 40 (02) : 199 - 207
  • [44] Health-related quality of life in patients given ciltacabtagene autoleucel for relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b-2, open-label study
    Martin, Thomas
    Lin, Yi
    Agha, Mounzer
    Cohen, Adam D.
    Htut, Myo
    Stewart, A. Keith
    Hari, Parameswaran
    Berdeja, Jesus G.
    Usmani, Saad Z.
    Yeh, Tzu-Min
    Olyslager, Yunsi
    Goldberg, Jenna D.
    Schecter, Jordan M.
    Madduri, Deepu
    Jackson, Carolyn C.
    Deraedt, William
    Gries, Katharine S.
    Fastenau, John M.
    Trudeau, Jeremiah J.
    Akram, Muhammad
    Pacaud, Lida
    Jakubowiak, Andrzej
    Jagannath, Sundar
    LANCET HAEMATOLOGY, 2022, 9 (12): : E897 - E905
  • [45] Comparative Efficacy of Ciltacabtagene Autoleucel in CARTITUDE-1 vs Physician’s Choice of Therapy in the Long-Term Follow-Up of POLLUX, CASTOR, and EQUULEUS Clinical Trials for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
    Katja Weisel
    Thomas Martin
    Amrita Krishnan
    Sundar Jagannath
    Anil Londhe
    Sandhya Nair
    Joris Diels
    Martin Vogel
    Jordan M. Schecter
    Arnob Banerjee
    Jesus G. Berdeja
    Tonia Nesheiwat
    Ashraf Garrett
    Keqin Qi
    Satish Valluri
    Saad Z. Usmani
    Kwee Yong
    Clinical Drug Investigation, 2022, 42 : 29 - 41
  • [46] Idecabtagene vicleucel (ide-cel; bb2121); a BCMA-directed CAR T cell therapy; for the treatment of patients with relapsed and refractory multiple myeloma (RRMM): updated results from KarMMa
    Einsele, Hermann
    Anderson, Larry D., Jr.
    Shah, Nina
    Jagannath, Sundar
    Berdeja, Jesus
    Lonial, Sagar
    Raje, Noopur
    Siegel, David S.
    Lin, Yi
    Moreau, Philippe
    Yakoub-Agha, Ibrahim
    Delforge, Michel
    Goldschmidt, Hartmut
    Weisel, Katja
    Cavo, Michele
    Reece, Donna
    Rambaldi, Alessandro
    Truppel-Hartmann, Anna
    Patel, Payal
    Huang, Liping
    Campbell, Timothy B.
    Hege, Kristen
    San-Miguel, Jesus
    Munshi, Nikhil C.
    Oriol, Albert
    ONCOLOGY RESEARCH AND TREATMENT, 2022, 45 (SUPPL 3) : 173 - 173
  • [47] A Matching-Adjusted Indirect Comparison of the Efficacy of Elranatamab and Teclistamab in Patients with Triple-Class Exposed/Refractory Multiple Myeloma
    Mol, Isha
    Hu, Yannan
    LeBlanc, Thomas W.
    Cappelleri, Joseph C.
    Chu, Haitao
    Nador, Guido
    Aydin, Didem
    Schepart, Alex
    Hlavacek, Patrick
    BLOOD, 2023, 142
  • [48] Ciltacabtagene Autoleucel for Triple-Class Exposed Multiple Myeloma: Adjusted Comparisons of CARTITUDE-1 Patient Outcomes Versus Therapies from Real-World Clinical Practice from the LocoMMotion Prospective Study
    Mateos, Maria-Victoria
    Weisel, Katja
    Martin, Thomas
    Berdeja, Jesus G.
    Jakubowiak, Andrzej
    Stewart, A. Keith
    Jagannath, Sundar
    Lin, Yi
    Diels, Joris
    Ghilotti, Francesca
    Perualila, Nolen J.
    Cabrieto, Jedelyn
    Haefliger, Benjamin
    Erler-Yates, Nichola
    Hague, Clare
    Jackson, Carolyn C.
    Strulev, Vadim
    Nesheiwat, Tonia
    Pacaud, Lida
    Moreau, Philippe
    Einsele, Hermann
    BLOOD, 2021, 138
  • [49] Comparative Efficacy of Ciltacabtagene Autoleucel in CARTITUDE-1 vs Physician's Choice of Therapy in the Long-Term Follow-Up of POLLUX, CASTOR, and EQUULEUS Clinical Trials for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
    Weisel, Katja
    Martin, Thomas
    Krishnan, Amrita
    Jagannath, Sundar
    Londhe, Anil
    Nair, Sandhya
    Diels, Joris
    Vogel, Martin
    Schecter, Jordan M.
    Banerjee, Arnob
    Berdeja, Jesus G.
    Nesheiwat, Tonia
    Garrett, Ashraf
    Qi, Keqin
    Valluri, Satish
    Usmani, Saad Z.
    Yong, Kwee
    CLINICAL DRUG INVESTIGATION, 2022, 42 (01) : 29 - 41
  • [50] An indirect treatment comparison of efficacy and health-related quality of life following treatment with idecabtagene vicleucel versus belantamab mafodotin in triple-class exposed relapsed/refractory patients with multiple myeloma
    Otero, Paula Rodriguez
    Towle, Kevin
    Cope, Shannon
    Caisip, Clyde
    Davies, Faith E.
    Delforge, Michel
    Weisel, Katja
    Marshall, Thomas S.
    Karampampa, Korinna
    Ayers, Dieter
    Mojebi, Ali
    Braverman, Julia
    Farrell, James
    Dhanda, Devender
    LEUKEMIA & LYMPHOMA, 2023, 64 (11) : 1864 - 1869