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

被引：409

作者：

Martin, Thomas ^{[1
]}

Usmani, Saad Z. ^{[2
]}

Berdeja, Jesus G. ^{[3
]}

Agha, Mounzer ^{[4
]}

Cohen, Adam D. ^{[5
]}

Hari, Parameswaran ^{[6
]}

Avigan, David ^{[7
]}

Deol, Abhinav ^{[8
]}

Htut, Myo ^{[9
]}

Lesokhin, Alexander ^{[2
]}

Munshi, Nikhil C. ^{[10
,11
]}

O'Donnell, Elizabeth ^{[12
]}

Stewart, A. Keith ^{[13
,14
]}

Schecter, Jordan M. ^{[15
]}

Goldberg, Jenna D. ^{[15
]}

Jackson, Carolyn C. ^{[15
]}

Yeh, Tzu-Min ^{[15
]}

Banerjee, Arnob ^{[16
]}

Allred, Alicia ^{[16
]}

Zudaire, Enrique ^{[16
]}

Deraedt, William ^{[17
]}

Olyslager, Yunsi ^{[17
]}

Zhou, Changwei ^{[18
]}

Pacaud, Lida ^{[18
]}

Madduri, Deepu ^{[15
]}

Jakubowiak, Andrzej ^{[19
]}

Lin, Yi ^{[20
]}

Jagannath, Sundar ^{[21
]}

机构：

[1] UCSF Helen Diller Family Comprehens Canc Ctr, San Francisco, CA USA

[2] Mem Sloan Kettering Canc Ctr, New York, NY USA

[3] Sarah Cannon Res Inst, Nashville, TN USA

[4] UPMC Hillman Canc Ctr, Pittsburgh, PA USA

[5] Univ Penn, Abramson Canc Ctr, Philadelphia, PA USA

[6] Med Coll Wisconsin, Milwaukee, WI USA

[7] Harvard Med Sch, Beth Israel Deaconess Med Ctr, Boston, MA USA

[8] Wayne State Univ, Karmanos Canc Inst, Detroit, MI USA

[9] City Hope Comprehens Canc Ctr, Duarte, CA USA

[10] Harvard Med Sch, Dana Farber Canc Inst, Boston, MA USA

[11] VA Boston Healthcare Syst, Boston, MA USA

[12] Harvard Med Sch, Massachusetts Gen Hosp, Boston, MA USA

[13] Univ Hlth Network, Toronto, ON, Canada

[14] Princess Margaret Canc Ctr, Toronto, ON, Canada

[15] Janssen R&D, Raritan, NJ USA

[16] Janssen R&D, Spring House, PA USA

[17] Janssen R&D, Beerse, Belgium

[18] Legend Biotech Inc, Piscataway, NJ USA

[19] Univ Chicago, Chicago, IL USA

[20] Mayo Clin Rochester, Rochester, MN USA

[21] Mt Sinai Med Ctr, New York, NY USA

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2023年 / 41卷 / 06期

关键词：

ORAL SELINEXOR; OUTCOMES; METAANALYSIS; MANAGEMENT;

D O I：

10.1200/JCO.22.00842

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：1265 / +

页数：15

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