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- Prescribing Information
- CARVYKTI® REMS
Primary analysis
98% OVERALL
RESPONSE RATE (95/97 95% CI: 92.7-99.7)a
RESPONSE RATE (95/97 95% CI: 92.7-99.7)a
78% STRINGENT
COMPLETE RESPONSE (76/97 95% CI: 68.8-86.1)ab
COMPLETE RESPONSE (76/97 95% CI: 68.8-86.1)ab
17% VERY GOOD
PARTIAL RESPONSE (16/97 95% CI: 9.7-25.4)a
PARTIAL RESPONSE (16/97 95% CI: 9.7-25.4)a
3% PARTIAL
RESPONSE (3/97 95% CI: 0.6-8.8)a
RESPONSE (3/97 95% CI: 0.6-8.8)a
21.8 MONTHS MEDIAN DURATION
OF RESPONSE (95% CI: 21.8-NE)a
OF RESPONSE (95% CI: 21.8-NE)a
aBased on a median duration of follow-up of 18 months.1
bAll complete responses were stringent complete responses.1
Dive deeper into the CARTITUDE-1 study and explore additional efficacy outcomes
CARVYKTI® (ciltacabtagene autoleucel) 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 a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
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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