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FDA approves ciltacabtagene autoleucel for the treatment of patients with RRMM

Mar 3, 2022
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On February 28, 2022, it was announced that the U.S. Food and Drug Administration (FDA) granted the approval of ciltacabtagene autoleucel (cilta-cel), a BCMA-directed chimeric antigen receptor T-cell therapy, for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) who have received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.1

The approval was based on the results of the CARTITUDE-1 trial (NCT03548207), a phase 1b/II, multicenter, single arm, open label study, which enrolled a total of 97 patients.1 Of note, 87.6% were triple-class refractory, and those who received previous BCMA-directed therapy were excluded from this trial.2 The 2-year follow-up results presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition showed2:

  • An overall response rate of 98%, with 83% achieving stringent complete response.
  • A median duration of response was not estimable (95% CI: 21.8 months–not estimable).
  • A 2-year progression-free survival and overall survival of 60.5% and 74%, respectively.
  • A total of 92% of patients achieving MRD negativity at 10−5.

The most common adverse reactions (occurring in ≥20% of patients) were pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections-pathogen unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting.1

It is important to note that the safety information includes a boxed warning regarding cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome (ICANS), Parkinsonism and Guillain-Barré syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and prolonged and/or recurrent cytopenia. Warnings and precautions also include prolonged and recurrent cytopenias, infections, hypogammaglobulinemia, hypersensitivity reactions, secondary malignancies, and effects on ability to drive and use machines.3

Currently, cilta-cel is being evaluated by the European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) and in various other clinical trials in the field of myeloma (see Table 1 below).

Table 1. Ongoing/planned clinical trials investigating ciltacabtagene autoleucel for the treatment of patients with multiple myeloma

Trial name
(NCT number)

Study title

Phase

CARTITUDE-2
(
NCT04133636)

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

II

CARTIFAN-1
(
NCT03758417)

A study of LCAR-B38M CAR-T cells, a chimeric antigen receptor T-cell (CAR-T) therapy directed against B-cell maturation antigen (BCMA) in Chinese participants with relapsed or refractory multiple myeloma

II

CARTITUDE-4
(
NCT04181827)

A study comparing JNJ-68284528, a CAR-T therapy directed against B-cell maturation antigen (BCMA), versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in participants with relapsed and lenalidomide-refractory multiple myeloma

III

CARTITUDE-5
(
NCT04923893)

A study of bortezomib, lenalidomide and dexamethasone (VRd) followed by cilta-cel, a CAR-T therapy directed against BCMA versus VRd followed by lenalidomide and dexamethasone (Rd) therapy in participants with newly diagnosed multiple myeloma for whom ASCT is not planned as initial therapy

III

CARTITUDE-6
(
NCT05257083)

A study of daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) followed by ciltacabtagene autoleucel versus daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) followed by autologous stem cell transplant (ASCT) in participants with newly diagnosed multiple myeloma

III

NCT05201781

A long-term study for participants previously treated with ciltacabtagene autoleucel

IV

  1. Legend Biotech. CARVYKTI™ (ciltacabtagene autoleucel), BCMA-directed CAR-T therapy, receives U.S. FDA approval for the treatment of adult patients with relapsed or refractory multiple myeloma. https://legendbiotech.com/wp-content/uploads/2022/02/CARVYKTI%E2%84%A2-ciltacabtagene-autoleucel-BCMA-Directed-CAR-T-Therapy-Receives-U.S.-FDA-Approval-2.pdf. Published Feb 28, 2022. Accessed Mar 1, 2022.
  2. Martin T. Updated results from CARTITUDE-1: Phase 1b/2 study of ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T cell therapy, in patients with relapsed/refractory multiple myeloma. Oral abstract #549. 63rd American Society of Hematology Annual Meeting & Exposition; Dec 12, 2021. Atlanta US.
  3. CARVYKTI™ (ciltacabtagene autoleucel) prescribing information. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/CARVYKTI-pi.pdf. Revised Feb 2022. Accessed Mar 1, 2022.

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