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 four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
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Median time to onset
1 DAY
Range: 1-23 days
Median duration
7 DAYS
Range: 1-63 days
9% Grade ≥3 (n=12)
85% All grades (n=108)
46% Grade 1 (n=58) /
30% Grade 2 (n=38) /
Grade 5 CRS was reported in one (0.8%) patient.
CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA.
Most common manifestations of CRS (N=127)
PYREXIA | 98% |
HYPOTENSION | 41% |
TACHYCARDIA | 35% |
CHILLS | 31% |
HYPOXIA | 20% |
FATIGUE | 12% |
HEADACHE | 10% |
Grade 3 or higher events that may be associated with CRS
Grade 3 or higher events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, ARDS, atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, multiple organ dysfunction syndrome, and HLH/MAS.
Treatment process includes leukapheresis, manufacturing, administration, and adverse event monitoring. A single dose of ABECMA contains a cell suspension of 300 to 460 x 106 CAR-positive T cells in one or more infusion bags.
Data at primary analysis. Safety profile remained consistent with longer follow-up and no new safety signals were observed.
Lee criterial for grading CRS (Lee et al, 2014)
ARs=adverse reactions; ARDS=acute respiratory distress syndrome; CAR=chimeric antigen receptor; CRS=cytokine release syndrome; HLH/MAS=hemophagocytic lymphohistiocytosis/macrophage activation syndrome; NT=neurologic toxicity.