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- CARVYKTI® REMS
In the pivotal CARTITUDE-1 study, patients treated with ciltacabtagene autoleucel demonstrated an ORR of 98% (95/97 95% CI: 92.7-99.7),a an sCR of 78% (76/97 95% CI: 68.8-86.1),ab a VGPR of 17% (16/97 95% CI: 9.7-25.4),a and a PR of 3% (3/97 95% CI: 0.6-8.8).a The mDOR was 21.8 months (95% CI: 21.8-NE).1
CI=confidence interval; NE=not estimable; ORR=overall response rate; PR=partial response; sCR=stringent complete response; VGPR=very good partial response.
aBased on a median duration of follow-up of 18 months.
bAll complete responses were stringent complete responses.
Efficacy Study design
Pivotal CARTITUDE-1 Study1-3
Phase 1b/2, open-label, multicenter trial of 97 adult patients with relapsed or refractory multiple myelomaa
Primary objectives
PHASE 1B
Characterize safety and confirm Phase 2 dose
PHASE 2
Evaluate efficacy:
- ORR (primary endpoint)
- sCR, CR, VGPR, DOR, TTR, TT≥CR, MRD-, PFS, OS (select secondary endpoints)
- The median time from leukapheresis to product availability was 32 days (range, 27-66 days)
- Of the 97 patients, 17 patients (18%) received ciltacabtagene autoleucel with manufacturing failures either because the product did not meet product release specifications or there were insufficient data to confirm the product release specifications for CARVYKTI®
CAR=chimeric antigen receptor; CR-complete response; DOR=duration of response; MRD=minimal residual disease negativity; ORR=overall response rate; OS=overall survival; PFS=progression free survival; sCR=stringent complete response; TT≥CR=time to complete response or better; TTR=time to response; VGPR=very good partial response.
aSee key eligibility criteria below.
bOne patient received retreatment with ciltacabtagene autoleucel.
Key eligibility criteria
- Diagnosis of multiple myeloma per IMWG criteria, with measurable disease
- ≥3 previous lines of therapy (or double refractory) to a proteasome inhibitor and an immunomodulatory agent
- Previous treatment with a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
- Disease progression per IMWG criteria within 12 months of last line of therapy
- ECOG performance status 0-1a
Exclusion criteria
- Known active or prior history of significant CNS disease including CNS multiple myeloma
- Plasma cell leukemia
- Allogeneic stem cell transplant within 6 months before apheresis or ongoing treatment with immunosuppressants
- Creatinine clearance <40 mL/min
- Absolute lymphocyte concentration <300/μL
- Absolute neutrophil count <750 cells/mm3
- Platelet count <50,000/mm3
- Hepatic transaminases >3x the upper limit of normal
- Cardiac ejection fraction <45%
- Active serious infection
- Prior treatment with CAR-T directed at any target
- Prior therapy that is targeted to BCMA
BCMA=B cell maturation antigen; CD38=cluster of differentiation 38; CNS=central nervous system; ECOG=Eastern Cooperative Oncology Group; IMWG=International Myeloma Working Group.
aECOG performance status at baseline was 2 in 4% of patients.
CARTITUDE-1 study: select baseline characteristics (N=97)1-3
DEMOGRAPHICS | |
---|---|
Age, range (median) | 43-78 years (61) |
Male (n) | 59% (57) |
African American (n) | 18% (17) |
ECOG performance status 0 (n) | 40% (39) |
ECOG performance status 1 (n) | 56% (54) |
ECOG performance status 2 (n) | 4% (4) |
DISEASE | |
---|---|
High-risk cytogenetic profile (n)a | 24% (23) |
Extramedullary plasmacytomas ≥1 (n) | 13% (13)b |
Tumor BCMA expression ≥50% (n) | 92% (57)c |
CrCl <45mL/min (n) | 3% (3) |
PRIOR TREATMENTS | |
---|---|
Time since diagnosis, median | 5.9 years |
Prior lines of therapy, median (range) | 6 (3-18) |
Triple-class exposed (n)d | 100% (97) |
Penta-exposed (n)e | 84% (81) |
Triple-class refractory (n)d | 88% (85) |
Penta-refractory (n)e | 42% (41) |
Refractory to last line of therapy (n) | 99% (96) |
Prior autologous transplant (n) | 90% (87) |
Previous allogeneic stem cell transplant (n) | 8% (8) |
BCMA=B cell maturation antigen; CD38=cluster of differentiation 38; CrCl=creatinine clearance; ECOG=Eastern Cooperative Oncology Group.
aBased on the presence of del(17p), t(14;16), or t(4;14).
bAdditional 6 patients had a soft-tissue component of a bone-based plasmacytoma (total plasmacytomas, 19.6%).
cDenominator n=62, the number of evaluable samples; BCMA expression detected in all evaluable samples.
d≥1 proteasome inhibitor, ≥1 immunomodulatory agent, and 1 anti-CD38 monoclonal antibody.
e≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and 1 anti-CD38 monoclonal antibody.
Deep responses
Nearly every patient achieved a clinical response
98% overall response rate (N=97; primary endpoint)a1

- Median time to first response was 1 month (range, 0.9-10.7)
ORR=overall response rate; PR=partial response; sCR=stringent complete response; VGPR=very good partial response.
aBased on a median duration of follow-up of 18 months.
bAll complete responses were stringent complete responses.
Durable responses
Median duration of response demonstrated in CARTITUDE-1a1

CI=confidence interval; mDOR=median duration of response; NE=not estimable; sCR=stringent complete response
abased on a median duration of follow-up of 18 months.
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