Reduction in the risk of disease
progression or death
vs standard therapy (DPd or PVd)2†
(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 (PI) and an immunomodulatory agent (IMID), and are refractory to lenalidomide.
NCCN
CATEGORY 1
THE FIRST AND ONLY CAR-T CELL THERAPY TO BE DESIGNATED AS NCCN CATEGORY 1 in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for multiple myeloma after 1 prior therapy3
Listed under “Therapy for Previously Treated Multiple Myeloma Relapsed/Refractory Disease After 1-3 Prior Therapies” as an option after 1 prior line of therapy, including an IMID and a PI, and refractory to lenalidomide.3
Additionally, ciltacabtagene autoleucel is designated as Category 2A after 3 prior therapies.3
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.2
2L=second-line; CAR-T=chimeric antigen receptor-T cell; CI=confidence interval; HR=hazard ratio; NCCN=National Comprehensive Cancer Network® (NCCN®); PFS=progression-free survival.
*From January 2021 to November 2024.
†15.9 months follow-up (Intent-to-Treat Analysis Set).
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