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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.
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
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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.
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. |