ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

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A Well-established Safety Profile After a One-time Infusion* of ABECMA®1



Patients received ABECMA across a dose range of 175 to 529 x 106 CAR-positive T cells (median dose: 445 x 106 CAR-positive T cells).

In KarMMa-3 (N=222):

  • One patient had grade 5, 2 patients had
    grade 4, and 2 patients had grade 3 HLH/MAS
  • Two cases of grade 3 and 1 case of grade 4 HLH/MAS had resolved

In KarMMa (N=127):

  • One patient treated in the 300 x 106 CAR-positive T cells dose cohort developed fatal multi-organ HLH/MAS with CRS
  • In another patient with fatal bronchopulmonary aspergillosis, HLH/MAS was contributory to the fatal outcome
  • Three cases of grade 2 HLH/MAS resolved

Across registrational studies (N=349):

  • HLH/MAS occurred in 2.9% (10/349) of patients
  • All events of HLH/MAS had onset within 10 days of receiving ABECMA and occurred in the setting of ongoing or worsening CRS
  • Median time to onset was 6.5 days (range: 4 to 10 days)
  • Five patients had overlapping neurotoxicity

HLH/MAS is a potentially life-threatening condition with a high mortality rate if not recognized early and treated. Treatment of HLH/MAS should be administered per institutional standards.

Treatment process includes leukapheresis, manufacturing, administration, and adverse event monitoring. A single dose of ABECMA contains a cell suspension of
300 to 510 x 106 CAR-positive T cells in 1 or more infusion bags.

Pooled registrational studies included KarMMa-3 and KarMMa (5L+).

CAR=chimeric antigen receptor; CRS=cytokene release syndrome; HLH/MAS=hemophagocytic lymphohistiocytosis/macrophage activation syndrome.

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