Multiple myeloma - March 2021

Multiple myeloma - March 2021

Pivotal study results of Idecabtagene Vicleucel in relapsed and refractory multiple myeloma published in New England Journal of Medicine

24 Feb 2021

Idecabtagene Vicleucel (ide-cel, bb2121 – BCMA-directed CAR T cell therapy) – BMS/bluebird bio

  • Clinically meaningful responses were reported in heavily pre-treated patients across all dose levels and in multiple high-risk subgroups, including those with high-risk cytogenetics, triple- or penta-refractory disease, high tumor burden at baseline, and extramedullary disease
  • Trial details: KarMMa; Phase 2 in multiple myeloma; N= 149; Idecabtagene Vicleucel 15 – 45 x 107 CAR+ T cells after receiving lymphodepleting chemotherapy; Primary outcomes: ORR; PCD: Nov’24; Active, not recruiting; Location: US, EU
  • Results: N= 140, median follow-up of 13.3 months
    • Minimal residual disease –negative status (<10−5 nucleated cells) was confirmed in 33 patients, representing 26% of all 128 patients who were treated and 79% of the 42 patients who had a complete response or better

      % of patients with treatment response

      73%

      CR

      33%

      mPFS

      8.8 mo

      Common toxic effects

      Neutropenia

      91%

      Anemia

      70%

      Thrombocytopenia

      63%

      CRS

      84%

      Neurotoxic effects

      18%

  • Conclusion:
    • Ide-cel induced responses in a majority of heavily pre-treated patients with refractory and relapsed myeloma; MRD-negative status was achieved in 26% of treated patients
    • Almost all patients had grade 3 or 4 toxic effects, most commonly hematologic toxic effects and cytokine release syndrome

Ide-cel showed clinically meaningful responses in heavily pre-treated multiple myeloma patients across all dose levels and in multiple high-risk subgroups

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CI Scientists Remarks:

  • About Ide-cel & MOA: It is a BCMA-directed genetically modified autologous CAR T cell immunotherapy. Ide-cel CAR is comprised of a murine extracellular scFv specific for recognizing BCMA, attached to a human CD8 α hinge and transmembrane domain fused to the T cell cytoplasmic signaling domains of CD137 4-1BB and CD3-ζ chain, in tandem
  • Ide-cel recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells
  • Regulatory status: Initial BLA for Ide-cel was filed in Mar’20 and FDA rejected citing “Chemistry, Manufacturing and Control (CMC) module of the BLA requires further detail to complete the review”
  • Refiling was done in Jul’20 addressing regulatory request, with a target action date of Mar 27, 2021
  • Future strategy: BMS/bluebird bio has a broad development program in multiple myeloma and is conducting multiple trials across different line of therapies

    KarMMa-2

    Multiple Myeloma Second Line (1 Prior)

    Phase 2

    KarMMa-3

    Multiple Myeloma Third Line (2-4 Prior)

    Phase 3

    KarMMa-4

    Multiple Myeloma First Line

    Phase 1

    KarMMa-7

    Multiple Myeloma Combinations Basket Study

    Planned

    KarMMa-8

    Multiple Myeloma 1-3 Prior Lines (2L Registrational)

    Planned

    KarMMa-9

    Multiple Myeloma NDMM (Registrational)

    Planned

– Dr. Kowndinya, CI Scientists

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