Ciltacabtagene Autoleucel, an Anti–B-cell Maturation Antigen Chimeric Antigen Receptor T-Cell Therapy, for Relapsed/Refractory Multiple Myeloma: CARTITUDE-1 2-Year Follow-Up

Author(s): Thomas Martin, MD1; Saad Z. Usmani, MD2; Jesus G. Berdeja, MD3; Mounzer Agha, MD4; Adam D. Cohen, MD5; Parameswaran Hari, MD6; David Avigan, MD7; Abhinav Deol, MD8; Myo Htut, MD9; Alexander Lesokhin, MD2; Nikhil C. Munshi, MD10,11; Elizabeth O’Donnell, MD12; A. Keith Stewart, MBChB13; Jordan M. Schecter, MD14; Jenna D. Goldberg, MD14; Carolyn C. Jackson, MD, MPH14; Tzu-Min Yeh, MS14; Arnob Banerjee, MD15; Alicia Allred, PhD15; Enrique Zudaire, PhD15; William Deraedt, MSc16; Yunsi Olyslager, MSc16; Changwei Zhou, PhD17; Lida Pacaud, MD17; Deepu Madduri, MD14; Andrzej Jakubowiak, MD18; Yi Lin, MD, PhD19; and Sundar Jagannath, MD20
Source: DOI: 10.1200/JCO.22.00842 Journal of Clinical Oncology 41, no. 6 (February 20, 2023) 1265-1274.
Maem Hussein MD

Dr. Maen Hussein's Thoughts

CAR-T for myeloma, impressive response rate, overall survival not reached.


CARTITUDE-1, a phase Ib/II study evaluating the safety and efficacy of ciltacabtagene autoleucel (cilta-cel) in heavily pretreated patients with relapsed/refractory multiple myeloma, yielded early, deep, and durable responses at 12 months. Here, we present updated results 2 years after last patient in (median follow-up [MFU] approximately 28 months), including analyses of high-risk patient subgroups.


Eligible patients had relapsed/refractory multiple myeloma, had received ≥ 3 prior lines of therapy or were double refractory to a proteasome inhibitor and immunomodulatory drug and had received prior proteasome inhibitor, immunomodulatory drug, and anti-CD38 therapy. Patients received a single cilta-cel infusion 5-7 days after lymphodepletion. Responses were assessed by an independent review committee.


At a MFU of 27.7 months (N = 97), the overall response rate was 97.9% (95% CI, 92.7 to 99.7); 82.5% (95% CI, 73.4 to 89.4) of patients achieved a stringent complete response. Median duration of response was not estimable. Median progression-free survival (PFS) and overall survival (OS) were not reached; 27-month PFS and OS rates were 54.9% (95% CI, 44.0 to 64.6) and 70.4% (95% CI, 60.1 to 78.6), respectively. Overall response rates were high across all subgroups (95.1%-100%). Duration of response, PFS, and/or OS were shorter in patients with high-risk cytogenetics, International Staging System stage III, high tumor burden, or plasmacytomas. The safety profile was manageable with no new cilta-cel–related cytokine release syndrome and one new case of parkinsonism (day 914 after cilta-cel) since the last report.


At approximately 28 months MFU, patients treated with cilta-cel maintained deep and durable responses, observed in both standard and high-risk subgroups. The risk/benefit profile of cilta-cel remained favorable with longer follow-up.

Author Affiliations

1UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA;2Memorial Sloan Kettering Cancer Center, New York, NY;3Sarah Cannon Research Institute, Nashville, TN;4UPMC Hillman Cancer Center, Pittsburgh, PA;5Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA;6Medical College of Wisconsin, Milwaukee, WI;7Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA;8Karmanos Cancer Institute, Wayne State University, Detroit, MI;9City of Hope Comprehensive Cancer Center, Duarte, CA;10Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA;11VA Boston Healthcare System, West Roxbury, MA;12Massachusetts General Hospital, Harvard Medical School, Boston, MA;13University Health Network and the Princess Margaret Cancer Centre, Toronto, ON, Canada;14Janssen R&D, Raritan, NJ;15Janssen R&D, Spring House, PA;16Janssen R&D, Beerse, Belgium;17Legend Biotech, Inc, Piscataway, NJ;18University of Chicago, Chicago, IL;19Mayo Clinic, Rochester, MN;20Mount Sinai Medical Center, New York, NY

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