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CARVYKTI - CARTITUDE-2 (MMY2003) Cohort E - Use in High-Risk NDMM, Transplant Not Planned

Last Updated: 11/06/2024

Summary

  • CARVYKTI is not approved by the regulatory agencies for use in newly diagnosed multiple myeloma (NDMM). Janssen does not recommend the use of CARVYKTI in a manner that is inconsistent with the approved labeling.
  • CARTITUDE-2 is a phase 2, multicohort, open-label study evaluating CARVYKTI in patients with multiple myeloma (MM) in various clinical settings. Cohort E is evaluating the efficacy and safety of CARVYKTI in patients with high-risk NDMM with no plan of autologous stem cell transplant (ASCT).1,2 The study is currently ongoing, and results have not been published yet for this cohort.

PRODUCT LABELING

CLINICAL DATA

CARTITUDE-2 (MMY2003; clinicaltrials.gov identifier: NCT04133636) is a phase 2, multicohort, open-label study evaluating CARVYKTI in patients with MM in various clinical settings.1,2

Cohort E of the CARTITUDE-2 study is evaluating the efficacy and safety of CARVYKTI in patients with high-risk NDMM with no plan of ASCT.1,2

Study Design/Methods

CARTITUDE-2 (Cohort E) Study Design1,2

Abbreviations: ASCT, autologous stem cell transplantation; CAR, chimeric antigen receptor; cilta-cel, ciltacabtagene autoleucel; CNS, central nervous system; Cy, cyclophosphamide; D-VRd, DARZALEX FASPRO + bortezomib + lenalidomide + dexamethasone; ECOG PS, Eastern Cooperative Oncology Group performance status; Flu, fludarabine; IMWG, International Myeloma Working Group; ISS, International Staginng System; MRD, minimal residual disease; NDMM, newly diagnosed multiple myeloma; NGS, next-generation sequencing; ORR, overall response rate; PR, partial response; SC, subcutaneous.
aOne cycle of prior therapy before enrollment was allowed.
bDel(17/17p), t(14;16), t(14;20), 1q amplification (≥4 total copies) in ≥20% of the total plasma cell population.
cDARZALEX FASPRO and bortezomib were administered as SC injections. Lenalidomide was administered orally. Dexamethasone was administered orally or intravenously.

Results

  • The study is currently ongoing, and results have not been published yet for this cohort.

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 06 November 2024.

References

1 Janssen Research & Development, LLC. A study of JNJ-68284528, a chimeric antigen receptor t cell (CAR-T) therapy directed against b-cell maturation antigen (BCMA) in participants with multiple myeloma (CARTITUDE-2). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2024 November 06]. Available from: https://clinicaltrials.gov/ct2/show/NCT04133636 NLM Identifier: NCT04133636.  
2 Einsele H, Van de Donk NCWJ, Arnulf B, et al. CARTITUDE-2 phase 2 multicohort study of ciltacabtageneautoleucel (cilta-cel), a B-cell maturation antigen (BCMA)–directed chimeric antigen receptor T (CAR-T) cell therapy, in patients with multiple myeloma (MM). Poster presented at: 7th World Congress on Controversies in Multiple Myeloma (COMy); May 7-9, 2021; Virtual meeting.