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
Abstract 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 immunomodul...
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| Format: | Article |
| Language: | English |
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Wiley
2022-02-01
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| Series: | eJHaem |
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| Online Access: | https://doi.org/10.1002/jha2.312 |
| _version_ | 1828716130849521664 |
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| author | Thomas Martin Amrita Krishnan Kwee Yong Katja Weisel Maneesha Mehra Sandhya Nair Keqin Qi Anil Londhe Joris Diels Concetta Crivera Carolyn C. Jackson Yunsi Olyslager Martin Vogel Jordan M. Schecter Arnob Banerjee Satish Valluri Saad Z. Usmani Jesus G. Berdeja Sundar Jagannath |
| author_facet | Thomas Martin Amrita Krishnan Kwee Yong Katja Weisel Maneesha Mehra Sandhya Nair Keqin Qi Anil Londhe Joris Diels Concetta Crivera Carolyn C. Jackson Yunsi Olyslager Martin Vogel Jordan M. Schecter Arnob Banerjee Satish Valluri Saad Z. Usmani Jesus G. Berdeja Sundar Jagannath |
| author_sort | Thomas Martin |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-03-12T14:06:52Z |
| format | Article |
| id | doaj.art-a405681420e34ef5b0861c5f9532c87e |
| institution | Directory Open Access Journal |
| issn | 2688-6146 |
| language | English |
| last_indexed | 2024-03-12T14:06:52Z |
| publishDate | 2022-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | eJHaem |
| spelling | doaj.art-a405681420e34ef5b0861c5f9532c87e2023-08-21T14:05:38ZengWileyeJHaem2688-61462022-02-01319710810.1002/jha2.312Comparative 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 myelomaThomas Martin0Amrita Krishnan1Kwee Yong2Katja Weisel3Maneesha Mehra4Sandhya Nair5Keqin Qi6Anil Londhe7Joris Diels8Concetta Crivera9Carolyn C. Jackson10Yunsi Olyslager11Martin Vogel12Jordan M. Schecter13Arnob Banerjee14Satish Valluri15Saad Z. Usmani16Jesus G. Berdeja17Sundar Jagannath18UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California USAJudy and Bernard Briskin Center for Multiple Myeloma Research Duarte California USAUniversity College Hospital London UKUniversity Medical Center Hamburg‐Eppendorf Hamburg GermanyJanssen Global Services LLC Raritan New Jersey USAJanssen Pharmaceutica NV Beerse BelgiumJanssen R&D LLC Titusville New Jersey USAJanssen R&D LLC Titusville New Jersey USAJanssen Pharmaceutica NV Beerse BelgiumJanssen Scientific Affairs LLC Horsham Pennsylvania USALevine Cancer Institute‐Atrium Health Charlotte North Carolina USAJanssen Pharmaceutica NV Beerse BelgiumJanssen Global Services LLC Raritan New Jersey USAJanssen R&D Raritan New Jersey USAJanssen R&D Raritan New Jersey USAJanssen Global Services LLC Raritan New Jersey USALevine Cancer Institute‐Atrium Health Charlotte North Carolina USASarah Cannon Research Institute Nashville Tennessee USAMount Sinai Medical Center New York New York USAAbstract 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.https://doi.org/10.1002/jha2.312CARTITUDE‐1ciltacabtagene autoleucelFlatiron Healthindirect treatment comparisonrelapsed or refractory multiple myelomatriple‐class exposed |
| spellingShingle | Thomas Martin Amrita Krishnan Kwee Yong Katja Weisel Maneesha Mehra Sandhya Nair Keqin Qi Anil Londhe Joris Diels Concetta Crivera Carolyn C. Jackson Yunsi Olyslager Martin Vogel Jordan M. Schecter Arnob Banerjee Satish Valluri Saad Z. Usmani Jesus G. Berdeja Sundar Jagannath 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 eJHaem CARTITUDE‐1 ciltacabtagene autoleucel Flatiron Health indirect treatment comparison relapsed or refractory multiple myeloma triple‐class exposed |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | CARTITUDE‐1 ciltacabtagene autoleucel Flatiron Health indirect treatment comparison relapsed or refractory multiple myeloma triple‐class exposed |
| url | https://doi.org/10.1002/jha2.312 |
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