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Ciltacabtagene autoleucel (cilta-cel), a BCMA-directed chimeric antigen receptor (CAR) T-cell therapy, is approved for the treatment of relapsed/refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Cilta-cel is currently under investigation as part of the CARTITUDE trials for expanding indications in MM and impact on patient-reported outcomes (PROs).
Here, we summarize presentations by Tessa Kerre and Roberto Mina from the 50th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) on the latest data from CARTITUDE-2 and CARTITUDE-4, respectively.
The phase II CARTITUDE-2 trial (NCT04133636) evaluated the safety and efficacy of cilta-cel in:
Table 1. Efficacy data from CARTITUDE-2*
Outcome, % (unless otherwise specified) |
Cohort A |
Cohort B |
---|---|---|
MRD negativity ×10−5 |
100 |
93.3 |
Sustained MRD negativity ×10−5 at ≥12 months |
50 |
61.5 |
MRD in ≥CR |
85 |
68.4 |
24-month DoR rate |
73.3 |
70.5 |
24-month PFS rate |
75 |
73 |
24-month OS rate |
75 |
84 |
CR, complete response; DoR, duration of response; MRD, measurable residual disease; OS, overall survival; PFS, progression-free survival. |
Figure 1. Response rates in cohort A and B from CARTITUDE-2*
CR, complete response; ORR, overall response rate; sCR, stringent complete response; VGPR, very good partial response.
*Adapted from Kerre.1
Figure 2. Clinically meaningful change in global health status at 12 months*
*Adapted from Mina.2
Table 2. EORTC QLQ-C30 LS mean change from baseline to Month 12*
Functional scale |
LS mean change from baseline |
|
---|---|---|
Cilta-cel (n = 99) |
SoC (n = 66) |
|
Cognitive |
0.5 (−2.4, 3.5) |
−7.5 (−11.2, −3.9) |
Emotional |
9.5 (6.6, 12.5) |
2.2 (−1.3, 5.7) |
Physical |
6.5 (3.8, 9.1) |
−2.1 (−5.0, 0.7) |
Role |
7.7 (3.7, 11.7) |
−1.7 (−6.3, 2.9) |
Social |
6.1 (2.1, 10.0) |
−0.1 (−4.2, 4.0) |
cilta cel, ciltacabtagene autoleucel; LS, least squares; SoC, standard of care. |
Key learnings1,2 |
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|
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