- For US Healthcare Professionals
- Prescribing Information
- CARVYKTI® REMS
NOW APPROVED
For patients who have received a PI and an immunomodulatory agent, and are lenalidomide-refractory1
AS EARLY AS
SECOND LINE IN RRMM
98% OVERALL
RESPONSE RATE (95/97 95% CI: 92.7-99.7)a
RESPONSE RATE (95/97 95% CI: 92.7-99.7)a
80% STRINGENT
COMPLETE RESPONSE (78/97 95% CI: 71.1-87.8)ab
COMPLETE RESPONSE (78/97 95% CI: 71.1-87.8)ab
14% VERY GOOD
PARTIAL RESPONSE (14/97 95% CI: 8.1-23.0)a
PARTIAL RESPONSE (14/97 95% CI: 8.1-23.0)a
3% PARTIAL
RESPONSE (3/97 95% CI: 0.6-8.8)a
RESPONSE (3/97 95% CI: 0.6-8.8)a
NOT REACHED MEDIAN DURATION
OF RESPONSE (95% CI: 23.3, NE)a
OF RESPONSE (95% CI: 23.3, NE)a
aBased on a median duration of follow-up of 28 months.1
bAll complete responses were stringent complete responses.1
Dive deeper into the CARTITUDE-1 study
PI=proteasome inhibitor; RRMM=relapsed or refractory multiple myeloma.
CARTITUDE-1 was a Phase 1b/2 open-label, multicenter study evaluating the efficacy and safety of a single infusion of ciltacabtagene autoleucel in adult patients with relapsed or refractory multiple myeloma who had previously received a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. In total, 97 patients were treated with ciltacabtagene autoleucel; all were evaluable for efficacy. Primary endpoint in Phase 1b was safety. Primary efficacy endpoint in Phase 2 was overall response rate; selected secondary endpoints included stringent complete response, very good partial response, minimal residual disease negativity, duration of response, progression-free survival, and safety.1,2
CD38=cluster of differentiation 38; CI=confidence interval; Deep=stringent complete response and very good partial response; NE=not estimable.
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