Secondary Endpoint: OS
Median follow-up of 33.6 months
reduction in the risk of death with CARVYKTI® vs standard therapy (DPd or PVd)
(HR=0.55; 95% CI: 0.39-0.79; P=0.001)1*†
Primary Endpoint: PFS
Median follow-up of 15.9 months
59% reduction in the risk of disease progression or death vs standard therapy (DPd or PVd)
(HR=0.41; 95% CI: 0.30-0.56; P<0.0001)1‡
Over 10,000 patients treated worldwide2§
CARVYKTI® is 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, 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
Ciltacabtagene autoleucel (CARVYKTI®) is 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 (CARVYKTI®) is designated as Category 2A after 3 prior therapies.3
§Through January 2026.
‖As part of 5-step process.
¶Through October 2025.
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 pomalidomide, bortezomid, 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; APP=advanced practice practitioner; CAR-T=chimeric antigen receptor-T cell; CI=confidence interval; cilta-cel=ciltacabtagene autoleucel; DPd=daratumumab, pomalidomide, and dexamethasone; HR=hazard ratio; NCCN=National Comprehensive Cancer Network® (NCCN®); OS=overall survival; PFS=progression-free survival; PI=proteasome inhibitor; PVd=pomalidomide, bortezomib, and dexamethasone; REMS=Risk Evaluation and Mitigation Strategy; RRMM=relapsed or refractory multiple myeloma.
*Median follow-up was 33.6 months in the Intent-to-Treat Analysis Set.
†Hazard ratio and 95% CI from a Cox proportional hazards model with treatment as the sole explanatory variable.
‡15.9-month median follow-up (Intent-to-Treat Analysis Set).
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