Cited by 25CAR-T cell therapy researchMultiple Myeloma Research and TreatmentsImmunotherapy and Immune Responses

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Ciltacabtagene Autoleucel (Cilta-cel), a BCMA-Directed CAR-T Cell Therapy, in Patients with Multiple Myeloma (MM) and Early Relapse after Initial Therapy: CARTITUDE-2 Cohort B 18-Month Follow-up

Abstract

Introduction: In cohort B of the multicohort phase 2 CARTITUDE-2 (NCT04133636) study, the efficacy and safety of cilta-cel are being evaluated in patients with multiple myeloma (MM) who had early relapse (≤12 months after autologous stem cell transplant [ASCT] or ≤12 months after start of initial treatment with anti-myeloma therapy). Because progression within 1 year of starting initial therapy is a poor prognostic factor, with overall survival <2 years in these patients, they have functionally high-risk disease and represent an unmet medical need. We present updated clinical results and cytokine analyses. Methods: Eligible patients had MM, received 1 prior line of therapy (proteasome inhibitor and immunomodulatory drug required), had early disease progression (≤12 mo after ASCT or ≤12 mo after start of anti-myeloma therapy for patients who did not undergo ASCT), and were treatment-naive to CAR-T/anti-B-cell maturation antigen (BCMA) therapies. Bridging therapy was allowed between apheresis and CAR-T cell infusion. A single cilta-cel infusion (target dose 0.75×106 CAR+ viable T cells/kg) was given post lymphodepletion. Safety and efficacy were assessed. The primary endpoint was minimal residual disease (MRD) negativity by next generation sequencing at 10-5. Management strategies were implemented to minimize risk of movement/neurocognitive treatment-emergent adverse events (MNTs)/parkinsonism. Pharmacokinetics, CAR-T cell phenotype, and cytokine profiles are also being investi…

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Crossref · 10.1182/blood-2022-159169

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  • The phase 2 CARTITUDE-2 trial showed efficacy of cilta-cel in small groups at earlier disease stages, with response rates of 95 to 100% and an estimated duration of response of at least 12 months in 79 to 89% of patients who had a response.

    “The phase 2 CARTITUDE-2 trial showed the efficacy of cilta-cel in small groups (cohorts A and B) at earlier disease stages, with response rates of 95 to 100% and an estimated duration of response of at least 12 months in 79 to 89% of patients who had a response.”
  • After approximately 1.5 years of follow-up in CARTITUDE-2, 75 to 90% of patients remained progression-free.

    “After approximately 1.5 years of follow-up, 75 to 90% of patients remained progressionfree. 13,14”
  • The results add to the consistently strong efficacy that cilta-cel has shown throughout its clinical development, including in similar early lines of therapy in CARTITUDE-2, and confirm the efficacy observed in heavily pretreated patients in CARTITUDE-1.

    “The results also add to the consistently strong efficacy that cilta-cel has shown throughout its clinical development, including in similar, early lines of therapy populations in CARTITUDE-2, 13,14 and confirm the efficacy observed in heavily pretreated patients who received cilta-cel in CARTITUDE-1. 10,11”

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Authors
Van De Donk, N. W., Agha, M., Cohen, A. D., Cohen, Y. C., Anguille, S., Kerre, T., Roeloffzen, W. W. H., Schecter, J. M., De Braganca, K. C., Jackson, C. C., Varsos, H., Mistry, P., Roccia, T., Xu, X., Li, K., Zudaire, E., Corsale, C., Akram, M., Geng, D., Pacaud, L., Sonneveld, P., & Zweegman, S.
Affiliations
  • Vrije Universiteit Amsterdam (NL)
  • UPMC Hillman Cancer Center (US)
  • University of Pennsylvania (US)
  • Tel Aviv University (IL)
  • University of Antwerp (BE)
  • Ghent University Hospital (BE)
  • University Medical Center Groningen (NL)
  • Janssen Research & Development (United States) (US)
  • 8Janssen Research & Development, Raritan, NJ
  • Janssen (United Kingdom) (GB)
  • 10Janssen Global Services, Raritan, NJ
  • 11Janssen Research & Development, Spring House, PA
  • Legend Biotech (United States) (US)
  • 13Erasmus Medical Center Cancer Institute, Rotterdam, Netherlands
Venue
Blood
Published
2022-11-15
Volume
140
Issue
Supplement 1
Pages
7536-7537
ISSN
  • 0006-4971 (ISSN-L)
  • 1528-0020
OpenAlex
W4310103705
Cited by
25
References
0
Citations by year
2026: 1 · 2025: 5 · 2024: 4 · 2023: 15
FWCI
2.52
Type
journal article
Language
en
Open access
closed
Locations
  • Blood (publishedVersion)
  • Ghent University Academic Bibliography (Ghent University) (publishedVersion)
Topics
  • Health Sciences › Medicine › Oncology › CAR-T cell therapy research
  • Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
  • Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
Keywords
cilta-cel, BCMA, CAR T-cell therapy, multiple myeloma, early recurrence, minimal residual disease negativity, autologous stem cell transplantation, cytokine release syndrome, movement disorders, pharmacokinetics, progression-free survival, overall survival, high-risk cytogenetics, treatment-naive patients

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