In the CARTITUDE-1 study at a median follow-up of 28 months, patients treated with CARVYKTI® demonstrated an ORR of 98% (95/97, 95% CI: 92.7-99.7), an sCR of 80% (78/97, 95% CI: 71.1-87.8), a VGPR of 14% (14/97, 95% CI: 8.1-23.0), and a PR of 3% (3/97, 95% CI: 0.6-8.8). The mDOR was not reached (95% CI: 23.3-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.

*All complete responses were sCRs.

Depth of Response

CARTITUDE-1 Study1*

Phase 1b/2, open-label, multicenter trial of 97 adult patients with relapsed or refractory multiple myeloma

Primary objectives1,2

PHASE 1b

Characterize safety and confirm Phase 2 dose

PHASE 2

Evaluate efficacy:

  • ORR (primary endpoint)
  • sCR, CR, VGPR, DOR, PFS, OS (select secondary endpoints)
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CARVYKTI® CARTITUDE-1 efficacy study design
  • The median time from leukapheresis to product availability was 32 days (range, 27-66 days)1
  • Of the 97 patients, 17 patients (18%) received CARVYKTI® 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®1

CAR=chimeric antigen receptor; CR=complete response; DOR=duration of response; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; sCR=stringent complete response; VGPR=very good partial response.

*See key eligibility criteria below.

Key Eligibility Criteria1,2

  • Diagnosis of MM per IMWG criteria, with measurable disease
  • ≥3 previous LoT (or double refractory to a PI and an immunomodulatory agent)
  • Previous treatment with a PI, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
  • Disease progression per IMWG criteria within 12 months of last LoT
  • ECOG PS 0-1*

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 PS=Eastern Cooperative Oncology Group performance status; IMWG=International Myeloma Working Group; LoT=line(s) of therapy; MM=multiple myeloma; PI=proteasome inhibitor.

*ECOG performance status at baseline was 2 in 4% of patients.2

cartitude-1 study: select baseline characteristics (n=97)1,2

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)*24% (23)
Extramedullary plasmacytomas ≥1 (n)13% (13)†
Tumor BCMA expression ≥50% (n)92% (57)‡
CrCl <45 mL/min (n)3% (3)
PRIOR TREATMENTS
Time since diagnosis, median5.9 years
Prior LoT, median (range)6 (3-18)
Triple-class exposed (n)§100% (97)
Penta-exposed (n)||84% (81)
Triple-class refractory (n)§88% (85)
Penta-refractory (n)||42% (41)
Refractory to LoT (n)99% (96)
Prior autologous stem cell 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; del=deletion; ECOG=Eastern Cooperative Oncology Group; LoT=line(s) of therapy; t(14;16)=translocation 14;16; t(4;14)=translocation 4;14.

*Based on the presence of del(17p), t(14;16), or t(4;14).1

†Additional 6 patients had a soft-tissue component of a bone-based plasmacytoma (total plasmacytomas, 19.6%).

‡Denominator n=62, the number of evaluable samples; BCMA expression detected in all evaluable samples.3

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

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

Two patients were refractory to other anti-CD38 antibodies.2

Median follow-up: 28 months

deep responses

In CARTITUDE-11,5

Nearly every patient achieved a clinical response AND MOST ACHIEVED A DEEP RESPONSE

Chart showing depth of response 98% ORR and 80% sCR

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

*Based on a median duration of follow-up of 28 months.1

†All complete responses were sCRs.1

Median follow-up: 28 months

DURABLE RESPONSES

In CARTITUDE-11*

mDOR in CARTITUDE-1

mDOR not reached (95% CI: 23.3-NE)¹

CI=confidence interval; mDOR=median duration of response; NE=not estimable.

*Based on a median duration of follow-up of 28 months.1

Median follow-up: 28 months

Progression-free survival

In CARTITUDE-14*

You are now viewing an analysis from the CARTITUDE-1 trial with a median duration of follow-up of 28 months. This information is not included in the current USPI and should be interpreted with caution.

  • PFS was a secondary endpoint in the CARTITUDE-1 trial and could not be statistically tested in the setting of a single-arm trial
  • The data are presented here for descriptive purposes only
Chart showing progression-free survival (PFS) rates in CARTITUDE-1
  • As of January 11, 2022, which was the data cutoff, 66 of the 97 patients who received CARVYKTI® 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.

*Based on a median duration of follow-up of 28 months.4

Overall Survival

In CARTITUDE-14*

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

CI=confidence interval; OS=overall survival.

*Based on a median duration of follow-up of 28 months.4

Median follow-up: 28 months

Time to Response

In CARTITUDE-11

CARVYKTI® CARTITUDE-1: infusion completed 1.0 month median time to first response

*Based on a median duration of follow-up of 28 months.1

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References

  1. CARVYKTI® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
  2. Berdeja JG, Madduri D, Usmani SZ, et al. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study. Lancet. 2021;398(10297):314-324.
  3. Madduri D, Berdeja JG, Usmani SZ, et al. CARTITUDE-1: phase 1b/2 study of ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T cell therapy, in relapsed/refractory multiple myeloma. Poster presented at: 62nd ASH Annual Meeting and Exposition; December 5-8, 2020; virtual.
  4. Martin T, Usmani SZ, Berdeja JG, et al. Ciltacabtagene autoleucel, an anti–B-cell maturation antigen chimeric antigen receptor T-cell therapy, for relapsed/refractory multiple myeloma: CARTITUDE-1 2-year follow-up. J Clin Oncol. 2022;JCO2200842. doi:10.1200/JCO.22.00842
  5. Data on file. Janssen Biotech, Inc.