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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33 to 78
years of age
(median age: 62)
37%
had high-risk
cytogenetics* (n=37)
36%
had extramedullary
plasmacytoma (n=36)
Characteristic | ABECMA |
---|---|
300-460 × 106 CAR-positive T cells (N=100) | |
Median age (range) – years | 62.0 (33-78) |
Age category, n (%) | |
<65 years | 64 (64) |
≥65 years | 36 (36) |
<75 years | 96 (96) |
≥75 years | 4 (4) |
Sex, n (%) | |
Male | 60 (60) |
Female | 40 (40) |
Race, n (%) | |
Asian | 2 (2) |
Black or African American | 6 (6) |
White | 78 (78) |
Unknown/Other | 14 (14) |
Ethnicity, n (%) | |
Hispanic or Latino | 8 (8) |
Not Hispanic or Latino | 80 (80) |
Not reported/Unknown | 12 (12) |
ECOG performance status,† n (%) | |
0 | 44 (44) |
1 | 53 (53) |
2 | 3 (3) |
Patients with extramedullary plasmacytoma, n (%) | 36 (36) |
Baseline cytogenetic high risk,*‡ n (%) | 37 (37) |
Revised iss stage at baseline (derived), n (%)§ | |
Stage I | 11 (11) |
Stage II | 71 (71) |
Stage III | 16 (16) |
Unknown | 2 (2) |
Median time since initial diagnosis, years (range) | 6 (1-18) |
Prior therapies | |
Prior SCT, n (%) | 92 (92) |
Median number of prior anti-MM regimens (range)ll | 6 (3-16) |
Creatinine clearance (mL/min), n (%) | |
<30 | 1 (1) |
30 to <45 | 7 (7) |
45 to <60 | 10 (10) |
60 to <80 | 26 (26) |
≥80 | 56 (56) |
Consider ABECMA for eligible patients with RRMM, including those with a poor prognosis.
Presence of t(4:14), t(14:16), and 17p13 del.
Three patients had ECOG performance status of <2 at screening for eligibility but subsequently deteriorated to ECOG performance status of ≥2 at baseline prior to start of lymphodepleting chemotherapy.
Baseline cytogenetic abnormality was based on baseline cytogenetics from central laboratory if available. If central laboratory was not available or was unknown, cytogenetics prior to screening was used.
Revised ISS was derived using baseline ISS stage, cytogenetic abnormality, and serum lactate dehydrogenase.
Induction with or without hematopoietic SCT and with or without maintenance therapy was considered a single regimen.
CAR=chimeric antigen receptor; ECOG=Eastern Cooperative Oncology Group; ISS=International Staging System; MM=multiple myeloma; RRMM=relapsed/refractory multiple myeloma; SCT=stem cell transplant.