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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
[Slide 1]
LEGEND
BIOTECH
MEDICAL AFFAIRS
POSTER ABSTRACT PA-010
Efficacy/Safety of a BCMA-directed
CAR-T Cell Therapy ± Lenalidomide
Maintenance in Patients With Multiple
Myeloma Who Had Suboptimal
Response to Frontline ASCT: Updated
Follow-Up From CARTITUDE-2 Cohort D
Dr. Yael Cohen (Tel Aviv University)
Exhibit Hall E, Metro Toronto Convention Centre
Toronto, Canada
September 19, 2025 | 10:30 AM - 4:30 PM EDT
CARTITUDE-2 provides cohort-specific evidence for cilta-cel in earlier treatment lines (including len-refractory mm post-1-3 lines and post-ASCT suboptimal responders). Complements CARTITUDE-4 pivotal phase 3 which established the ≥1 prior line approval. Informs clinical decision-making for patient selection.
Medians not reached across cohorts A/B (median follow-up ~29 months). Cohort A 12-month OS 91%; Cohort B 24-month OS 75-84%. Long-term follow-up continues.
Key AEs: Cytokine release syndrome (CRS), ICANS, other neurotoxicities. Most CRS and ICANS events resolved across all cohorts. No new CAR-T safety signals vs. CARTITUDE-1. Delayed non-ICANS neurotoxicities (movement and neurocognitive events) remain a CARVYKTI class effect requiring monitoring.
⚠️ Supportive phase 2 data — not the basis of FDA approval. CARTITUDE-2 provides cohort-specific evidence for cilta-cel in earlier treatment lines (including len-refractory mm post-1-3 lines and post-ASCT suboptimal responders). Complements CARTITUDE-4 pivotal phase 3 which established the ≥1 prior line approval. Informs clinical decision-making for patient selection.