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(HR=0.41; 95% CI: 0.30-0.56) P<0.0001
CARVYKTI® 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 (RRMM) who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.
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CARTITUDE-4 is a randomized, open label, multicenter controlled study evaluating the efficacy and safety of CARVYKTI® for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma, who previously received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. A total of 419 patients were randomized 1:1 to receive either CARVYKTI® (n=208) or standard therapy which included daratumumab, pomalidomide, and dexamethasone (DPd) or bortezomib, pomalidomide, and dexamethasone (PVd) selected by physician prior to randomization based on patient’s prior antimyeloma therapy (n=211). The primary efficacy measure was PFS analyzed based on the Intent-to-Treat Analysis Set.1
2L=second-line; CI=confidence interval; HR=hazard ratio; PI=proteasome inhibitor.
*15.9 months follow-up (Intent-to-Treat Analysis Set).
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