TY - JOUR
T1 - Ciltacabtagene Autoleucel, an Anti-B-cell Maturation Antigen Chimeric Antigen Receptor T-Cell Therapy, for Relapsed/Refractory Multiple Myeloma
T2 - CARTITUDE-1 2-Year Follow-Up
AU - Martin, Thomas
AU - Usmani, Saad Z.
AU - Berdeja, Jesus G.
AU - Agha, Mounzer
AU - Cohen, Adam D.
AU - Hari, Parameswaran
AU - Avigan, David
AU - Deol, Abhinav
AU - Htut, Myo
AU - Lesokhin, Alexander
AU - Munshi, Nikhil C.
AU - O'donnell, Elizabeth
AU - Stewart, A. Keith
AU - Schecter, Jordan M.
AU - Goldberg, Jenna D.
AU - Jackson, Carolyn C.
AU - Yeh, Tzu Min
AU - Banerjee, Arnob
AU - Allred, Alicia
AU - Zudaire, Enrique
AU - Deraedt, William
AU - Olyslager, Yunsi
AU - Zhou, Changwei
AU - Pacaud, Lida
AU - Madduri, Deepu
AU - Jakubowiak, Andrzej
AU - Lin, Yi
AU - Jagannath, Sundar
N1 - Funding Information:
We thank the patients who volunteered to participate in the study, their families and caregivers, the physicians and nurses who cared for the patients and supported this clinical trial, staff members at the 16 US study sites who enrolled patients, and staff members involved in data collection and analysis. Medical writing support was provided by Andreja Varjacic, PhD, Karen Pemberton, PhD, and Julie Nowicki, PhD, of Eloquent Scientific Solutions and was funded by Janssen Global Services.
Funding Information:
Supported by Janssen Research & Development, LLC, and Legend Biotech, Inc.
Funding Information:
The Supported by Janssen Research and Development, LLC, and Legend Biotech, Inc.
Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2022/5/1
Y1 - 2022/5/1
N2 - PURPOSECARTITUDE-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.METHODSEligible 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.RESULTSAt 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.CONCLUSIONAt 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.
AB - PURPOSECARTITUDE-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.METHODSEligible 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.RESULTSAt 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.CONCLUSIONAt 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.
UR - http://www.scopus.com/inward/record.url?scp=85134581882&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85134581882&partnerID=8YFLogxK
U2 - 10.1200/JCO.22.00842
DO - 10.1200/JCO.22.00842
M3 - Article
C2 - 35658469
AN - SCOPUS:85134581882
SN - 0732-183X
VL - 19
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
M1 - JCO.22.00842
ER -