In KarMMa, no grade 3 or higher parkinsonian or motor symptoms were observed.3§
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
2 DAYS
Range: 1-42 days
Median duration
5‡ DAYS
In 33 of 36 patients
who had resolved NT
Range: 1-61 days
In 33 of 36 patients
who had resolved NT
4% Grade 3 (n=5)
28% All grades (n=36)
4%
28%
All grades
(n=36)
17% Grade 1 (n=21) /
8% Grade 2 (n=10) /
There were no grade 4 or 5 NT events in KarMMa.
*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.
‡For patients who experienced NT, including 3 patients with ongoing NT, the median duration of CAR T cell-associated NT was 6 days (range: 1 to 578 days).
Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS (n=34), with onset during CRS (n=29), before CRS (n=3), after CRS resolution (n=2), or in the absence of CRS.
In KarMMa, no grade 3 or higher parkinsonian or motor symptoms were observed.3§
Grade 3 myelitis and Grade 3 parkinsonism have occurred after treatment with ABECMA in another study in multiple myeloma. NCI CTCAE criteria (version 4.03) utilized for grading neurologic toxicities.
Most common (≥5%) manifestations of NT (N=127)
Encephalopathy | 20% |
Tremor | 9% |
Aphasia | 7% |
Delirium | 6% |
ARs=adverse reactions; CAR=chimeric antigen receptor; CRS=cytokine release syndrome; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events; NT=neurologic toxicity.