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CARTITUDE PROGRAM
CARTITUDE-1 (n=97) Accelerated FDA Approval: 2/22/2022. ?? Cure in RRMM
CARTITUDE-2 (multi-cohort)
A - Cilta-cel in patients with RRMM having received 1-3 PLT, Len refractory
B - Cilta-cel in patients with RRMM s/p 1 PLT AND early relapse (<12m)
C - Cilta-cel in TCE patients and exposure to BCMA therapy (non-CAR)
D- Cilta-cel in NDMM patients without CR after Ind/SCT/Consol (4-8 cycles)
E- HR-NDMM => D-RVd + Ciltacel + DR maintenance as frontline therapy
CARTITUDE-4 (n=419) CART vs. SOC triplets
Full FDA Approval
CARTITUDE-5 (n=650) Phase 3: TI - VRD+Rd vs. VRD+Cilta-cel (Accrued)
CARTITUDE-6 (n=750) Phase 3: TE - D-VRd/ASCT vs. D-VRD+ Cilta (Accrued)
a
About the CARTITUDE-6 / EMagine (MMY3005 / EMN28) Trial
CARTITUDE-6 (EMagine) is the pivotal trial positioning cilta-cel as a potential front-line option in transplant-eligible NDMM. Direct competitor: MajesTEC-5 (teclistamab-based front-line). Results will determine whether CAR-T moves to first-line or remains reserved for relapsed disease.
Phase 3 randomized comparison of cilta-cel vs. standard of care (DVRd induction + ASCT + lenalidomide maintenance) in transplant-eligible NDMM. Preliminary cilta-cel arm signals include 85.6% MRD negativity at 10⁻⁶ in non-randomized cohorts. No primary endpoint readout yet.
Safety in front-line cohorts to be fully characterized at primary analysis. CAR-T class effects (CRS, ICANS, delayed neurotoxicity) remain monitored per established CARVYKTI REMS.
⚠️ Ongoing phase 3 — potential front-line CAR-T paradigm shift. CARTITUDE-6 (EMagine) is the pivotal trial positioning cilta-cel as a potential front-line option in transplant-eligible NDMM. Direct competitor: MajesTEC-5 (teclistamab-based front-line). Results will determine whether CAR-T moves to first-line or remains reserved for relapsed disease.
Major Media & Publications
CARTITUDE-6 / EMagine (MMY3005 / EMN28) in the News