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Efficacy | CARVYKTI® (ciltacabtagene autoleucel) HCP

In the pivotal CARTITUDE-1 study at a median follow-up of 18 months, patients treated with ciltacabtagene autoleucel demonstrated an ORR of 98% (95/97 95% CI: 92.7-99.7), an sCR of 78% (76/97 95% CI: 68.8-86.1),a a VGPR of 17% (16/97 95% CI: 9.7-25.4), and a PR of 3% (3/97 95% CI: 0.6-8.8). The mDOR was 21.8 months (95% CI: 21.8-NE).1

CI=confidence interval; mDOR=median duration of response; NE=not estimable; ORR=overall response rate; PR=partial response; sCR=stringent complete response; VGPR=very good partial response.

aAll complete responses were sCRs.1

 

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®
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Study design flow chart showing enrolled & leukaphereses, underwent lymphodepletion, treated with ciltacabtagene autoleucel

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; CAR-T=chimeric antigen receptor–T cell; 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 <45 mL/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).1,2

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.4

d≥1 proteasome inhibitor, ≥1 immunomodulatory agent, and 1 anti-CD38 monoclonal antibody.2

e≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and 1 anti-CD38 monoclonal antibody.2

Primary analysis

Follow-up analysis

Median follow-up: 18 months

Deep responsesa

Nearly every patient achieved a clinical response1

98% overall response rate (N=97; primary endpoint)a1

Chart showing patient overall response rate (ORR)

CI=confidence interval; deep=stringent complete response and very good partial response; 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.1

bAll complete responses were sCRs.1

Median follow-up: 28 months

Depth of responsesa5,6

Clinical response in CARTITUDE-1

You are now viewing the subsequent follow-up analysis of the cartitude-1 trial. This information is not included in the current USPI
Chart with patient depth of response percentage

CI=confidence interval; ORR=overall response rate; PR=partial response; sCR=stringent complete response; VGPR=very good partial response; USPI=US Prescribing Information.

aBased on a median duration of follow-up of 27.7 months.5

bAll complete responses were sCRs.5

Primary analysis

Follow-up analysis

Median follow-up: 18 months

Durable Responsesa

Median duration of response demonstrated in CARTITUDE-11

21.8 months mDOR (95% CI:21.8-NE) mDOR for sCR not reached (95% CI:21.8-NE)

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.1

bAt a median follow-up of 18 months, the mDOR (21.8 months [95% CI: 21.8-NE]) was an unstable estimate due to a limited number of responders with progressive disease. As a result, a single patient's progression had an outsized impact on the model's estimate. After longer patient follow-up, the mDOR at a median follow-up of 27.7 months was determined to be not yet estimable.1,3,5,6

Median follow-up: 28 months

Duration of response5

mDOR in CARTITUDE-1

You are now viewing the subsequent follow-up analysis of the cartitude-1 trial. This information is not included in the current USPI
mDOR not reached (95% CI:23.3-NE)

At a median follow-up of 18 months, the mDOR (21.8 months [95% CI: 21.8-NE]) was an unstable estimate due to a limited number of responders with progressive disease. As a result, a single patient's progression had an outsized impact on the model's estimate. After longer patient follow-up, the mDOR at a median follow-up of 27.7 months was determined to be not yet estimable.1,3,5,6

CI=confidence interval; mDOR=median duration of response; NE=not estimable; USPI=US Prescribing Information.

Median follow-up: 28 months

Progression-free survivala5

PFS in CARTITUDE-1

You are now viewing the subsequent follow-up analysis of the cartitude-1 trial. This information is not included in the current USPI
Survival rate chart: 27-month rate: PFS for all patients 54.9%. 27-month rate PFS for sCR patients: 64.2%
mPFS not reached for all patients
  • PFS was a secondary endpoint in the CARTITUDE-1 trial and could not be statistically tested in the setting of a single-arm trial
  • PFS data are not in the USPI and should be interpreted with caution
  • The data are presented here for descriptive purpose only
  • As of January 11, 2022, which was the data cutoff, 66 of the 97 patients who received cilta-cel infusion remain in the study. Thirty patients have died and 1 withdrew from the study

CI=confidence interval; mPFS=median progression-free survival; NE=not estimable; PFS=progression-free survival; sCR=stringent complete response; USPI=US Prescribing Information.

aBased on a median duration of follow-up of 27.7 months.5

Overall Survivala5

OS IN CARTITUDE-1

Median OS was not reached. The 27-month OS rate in the overall population was 70.4%
  • OS was a secondary endpoint in the CARTITUDE-1 trial and could not be statistically tested in the setting of a single-arm trial
  • OS data are not in the USPI and should be interpreted with caution
  • The statistical significant of OS is not known
  • The data are presented here for descriptive purpose only
  • As of January 11, 2022, which was the data cutoff, 66 of the 97 patients who received cilta-cel infusion remain in the study. Thirty patients have died and 1 withdrew from the study

CI=confidence interval; OS=overall survival; USPI=US Prescribing Information.

aBased on a median duration of follow-up of 27.7 months.5

Median follow-up: 28 months

Time to Responsea5

You are now viewing the subsequent follow-up analysis of the cartitude-1 trial. This information is not included in the current USPI
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Time to response chart showing Carvykti infusion completed at 1 month, 2.6 months, and 2.9 months

CR=complete response; USPI=US Prescribing Information.

aBased on a median duration of follow-up of 27.7 months.5

bThe median time to first response is also included in the current USPI.1

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