INDICATION

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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PFS Analyses Across a Broad Set of Patient Subgroups1

Analysis limitations: These analyses are exploratory in nature and definitive conclusions should not be drawn.

PFS Across Patient Subgroups in ABECMA KarMMa-3 Trial
0.51 (0.39-0.66)
All subjects
149/254
93/132
Total patient population
N
ORR
LCL
UCL
0
10
20
30
40
50
60
70
80
90
100
 
100
72
62
81
Age group
HR (95% CI)
ABECMA®
Standard
Regimens
0.0
0.4
0.8
1.2
1.6
2.0
2.4
2.8
Age group: <65
 
0.57 (0.40-0.80)
93/150
51/78
Age group: ≥65
 
0.43 (0.28-0.64)
56/104
42/54
Age group: 65-74
 
0.42 (0.27-0.65)
49/92
36/45
Age group: 75-84
 
0.59 (0.19-1.78)
7/12
6/9
Region
HR (95% CI)
ABECMA
Standard
Regimens
0.0
0.4
0.8
1.2
1.6
2.0
2.4
2.8
Region: North America
 
0.50 (0.36-0.70)
84/144
60/82
Region: Europe
.
 
0.44 (0.28-0.68)
63/106
32/45
Region: Japan
.
 
NC
2/4
1/5
Sex / Race / Ethnicity
HR (95% CI)
ABECMA
Standard
Regimens
0.0
0.4
0.8
1.2
1.6
2.0
2.4
2.8
Sex: Male
 
0.53 (0.38-0.75)
92/156
55/79
Sex: Female
.
 
0.47 (0.31-0.71)
57/98
38/53
Sex / Race / Ethnicity
HR (95% CI)
ABECMA
Standard
Regimens
0.0
0.4
0.8
1.2
1.6
2.0
2.4
2.8
Race: White
 
0.52 (0.37-0.73)
101/172
54/78
Race: Non-white
 
0.59 (0.29-1.22)
14/28
18/27
Sex / Race / Ethnicity
HR (95% CI)
ABECMA
Standard
Regimens
0.0
0.4
0.8
1.2
1.6
2.0
2.4
2.8
Race: White
 
0.52 (0.37-0.73)
101/172
54/78
Race: Asian
 
NC
4/7
1/5
Race: African American
 
0.50 (0.20-1.23)
8/18
13/18
Race: Other
 
NC
2/3
4/4
Sex / Race / Ethnicity
HR (95% CI)
ABECMA
Standard
Regimens
0.0
0.4
0.8
1.2
1.6
2.0
2.4
2.8
Ethnicity: Hispanic or Latino
 
0.21 (0.05-0.93)
5/11
5/8
Ethnicity: Not Hispanic or Latino
 
0.56 (0.41-0.76)
109/188
68/98
Anti-CD38 class refractory
HR (95% CI)
ABECMA
Standard
Regimens
0.0
0.4
0.8
1.2
1.6
2.0
2.4
2.8
Anti-CD38 class refractory: Yes
 
0.51 (0.39-0.67)
143/242
88/124
Anti-CD38 class refractory: No
 
0.40 (0.11-1.40)
6/12
5/8
Daratumumab refractory
HR (95% CI)
ABECMA
Standard
Regimens
0.0
0.4
0.8
1.2
1.6
2.0
2.4
2.8
Daratumumab refractory: Yes
 
0.51 (0.39-0.67)
143/242
88/123
Daratumumab refractory: No
 
0.40 (0.11-1.40)
6/12
65/9
Double-class (immunomodulatory
agent and PI) refractory
HR (95% CI)
ABECMA
Standard
Regimens
0.0
0.4
0.8
1.2
1.6
2.0
2.4
2.8
Double-class (immunomodulatory agent and PI)
refractory: Yes
 
0.47 (0.34-0.63)
106/169
72/91
Double-class (immunomodulatory agent and PI)
refractory: No
 
0.65 (0.38-1.11)
43/85
21/41
Triple-class refractory
HR (95% CI)
ABECMA
Standard
Regimens
0.0
0.4
0.8
1.2
1.6
2.0
2.4
2.8
Triple-class refractory: Yes
 
0.46 (0.34-0.62)
103/164
70/89
Triple-class refractory: No
 
0.65 (0.39-1.09)
46/90
23/43
Penta-refractory
HR (95% CI)
ABECMA
Standard
Regimens
0.0
0.4
0.8
1.2
1.6
2.0
2.4
2.8
Penta-refractory: Yes
 
0.63 (0.17-2.33)
12/15
3/5
Penta-refractory: No
 
0.49 (0.37-0.64)
137/239
90/127
R-ISS stage at baseline
HR (95% CI)
ABECMA
Standard
Regimens
0.0
0.4
0.8
1.2
1.6
2.0
2.4
2.8
R-ISS stage at baseline: I or II
 
0.48 (0.36-0.64)
113/200
78/108
R-ISS stage at baseline: III
 
0.86 (0.39-1.92)
27/31
8/14
Tumor burden
HR (95% CI)
ABECMA
Standard
Regimens
0.0
0.4
0.8
1.2
1.6
2.0
2.4
2.8
Tumor burden: <50%
 
0.47 (0.34-0.65)
99/172
60/90
Tumor burden: ≥50%
 
0.60 (0.37-0.97)
44/71
28/34
Extramedullary plasmacytoma
HR (95% CI)
ABECMA
Standard
Regimens
0.0
0.4
0.8
1.2
1.6
2.0
2.4
2.8
Extramedullary plasmacytoma: Yes
 
0.40 (0.25-0.65)
48/61
28/32
Extramedullary plasmacytoma: No
 
0.51 (0.37-0.70)
100/192
65/100
Number of prior anti-myeloma regimens
HR (95% CI)
ABECMA
Standard
Regimens
0.0
0.4
0.8
1.2
1.6
2.0
2.4
2.8
Number of prior anti-myeloma regimens: 2
 
0.51 (0.31-0.84)
41/78
26/39
Number of prior anti-myeloma regimens: 3 or 4
 
0.51 (0.37-0.69)
108/176
67/93
Number of prior anti-myeloma regimens
HR (95% CI)
ABECMA
Standard
Regimens
0.0
0.4
0.8
1.2
1.6
2.0
2.4
2.8
Number of prior anti-myeloma regimens: 2
 
0.51 (0.31-0.84)
41/78
26/39
Number of prior anti-myeloma regimens: 3
 
0.44 (0.29-0.68)
57/95
37/49
Number of prior anti-myeloma regimens: 4
 
0.58 (0.36-0.92)
51/81
30/44
High-risk cytogenetic abnormalities
HR (95% CI)
ABECMA
Standard
Regimens
0.0
0.4
0.8
1.2
1.6
2.0
2.4
2.8
High-risk cytogenetic abnormalities: Presence
 
0.61 (0.41-0.90)
65/107
42/61
High-risk cytogenetic abnormalities:
Absence or unknown
 
0.44 (0.31-0.63)
84/147
51/71

The standard regimens consisted of 5 antimyeloma treatment options: DPd, DVd, IRd, Kd, or EPd, selected by Investigator contingent upon the patient’s most recent antimyeloma treatment.2

Efficacy based on follow-up at the primary PFS analysis (median follow-up of 15.9 months (95% CI, 14.1-18.0)).2

NC=not calculated; PI=proteasome inhibitor; R-ISS=Revised International Staging System.


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