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2024-03-07T14:45:42.000Z

CARTITUDE-2 cohorts A and B: Updated efficacy and safety results

Mar 7, 2024
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Learning objective: After reading this article, learners will be able to cite a new clinical development in multiple myeloma.

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The phase II CARTITUDE-2 trial (NCT04133636) evaluated safety and efficacy of the B-cell maturation antigen-directed chimeric antigen receptor T-cell agent ciltacabtagene autoleucel for treatment of relapsed/refractory multiple myeloma.

During 2024 Transplantation & Cellular Therapy Meetings of the ASTCT and CIMBTR (TANDEM), Hillengass.1 presented updated results from the CARTITUDE-2 trial. We summarize the key results below.

Study design1

  • Cohort A: patients with 1–3 prior lines of therapy
  • Cohort B: patients who relapsed at ≤12 months after transplant/at antimyeloma treatment initiation if without transplant
  • All patients received a target dose of 0.75 × 106 cells/kg.
  • The primary endpoint was negative measurable residual disease at a sensitivity of 10−5.

Key findings1

  • Cohort A = 20 patients
  • Cohort B = 19 patients
  • Median follow-up 29 months
  • Most patients across both cohorts achieved negative measurable residual disease (Figure 1).

Figure 1. Rates of overall and sustained negative MRD in cohorts A and B from CARTITUDE-2 l* 

MRD, measurable residual disease.
*Adapted from Hillengass.1
†Cohort A (n = 17), cohort B (n = 15).
‡Cohort A (n = 11), cohort B (n = 13).
§Cohort A (n = 14), cohort B (n = 13).

  • Duration of response, overall survival and progression free survival rates at 24 months were comparable between the two patient cohorts (Table 1).

Table 1. ORR and OS, PFS and DOR rate at 24 months*

Cohort A
(n = 20)

Cohort B
(n = 19)

ORR, %

95

100

OS at 24 months, %

75.1

84.2

PFS at 24 months, %

75

73.3

DOR at 24 months, %

73.3

70.5

DOR, duration of response; ORR, overall response rate; OS, overall survival; PFS, progression free survival.
*Adapted from Hillengass.1

  • Most Grade 3/4 hematologic treatment related adverse events were experienced by more patients in cohort A vs cohort B (Table 2).

Table 2. Cytokine release syndrome, ICANS, and Grade 3/4 hematologic TRAE*

%, unless otherwise stated

Cohort A
(n = 20)

Cohort B
(n = 19)

Any grade CRS

95

84.2

Any grade ICANS

15

5.3

Hematologic TRAE

Neutropenia

95

89.5

Lymphopenia

80

47.4

Thrombocytopenia

40

26.3

Anemia

45

47.4

Leukopenia

60

31.6

CRS, cytokine release syndrome; ICANS, immune cell associated neurotoxicity syndrome, TRAE, treatment-related adverse event.
*Adapted from Hillengass.1

Key learnings

  • Deep and durable responses were observed with ciltacabtagene autoleucel in earlier lines of treatment, and in patients who experienced early relapse; a population with a current unmet treatment need.
  • These results also provide an early insight into potential clinical outcomes for the ongoing CARTITUDE-4 trial (NCT04181827).

  1. Hillengass J. The phase 2 Cartitude-2 trial: Updated efficacy and safety of ciltacabtagene autoleucel in patients with multiple myeloma and 1–3 prior lines of therapy (cohort A) and with early relapse after first line treatment (cohort B). Oral abstract #42. 2024 Transplantation and Cellular Therapy Meetings of the ASTCT and CIMBTR; Feb 23, 2024; San Antonio, US.

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