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 - 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 - https://www.scopus.com/pages/publications/85134581882
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 -