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

Early death

  • In KarMMa-3, a randomized (2:1), controlled trial, a higher proportion of patients experienced death within 9 months after randomization in the ABECMA arm (45/254; 18%) compared with the standard regimen arm (15/132; 11%)
  • Early deaths occurred in 8% (20/254) and 0% of patients prior to ABECMA infusion and standard regimen administration infusion, respectively, and in 10% (25/254) and 11% (15/132) after ABECMA infusion and standard regimen infusion administration, respectively
  • Of the 20 deaths that occurred prior to ABECMA infusion, 15 occurred from disease progression, 3 occurred from adverse events, and 2 occurred from unknown causes. Of the 25 deaths that occurred after ABECMA infusion, 10 occurred from disease progression, 11 occurred from adverse events, and 4 occurred from unknown causes

Before selecting ABECMA please consider the KarMMa-3 trial design, such as patient inclusion criteria and treatment approach.

Secondary malignancies

  • In KarMMa-3, myeloid neoplasms (4 cases of myelodysplastic syndrome and 1 case of acute myeloid leukemia) occurred in 2.2% (5/222) of patients following treatment with ABECMA compared with none in the control arm at the time of the safety update
  • Median time to onset of myeloid neoplasm from ABECMA infusion was 338 days (range: 277 to 794 days); 3 out of 5 of these patients died following the development of myeloid neoplasm

T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA. Monitor life-long for secondary malignancies.

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.

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