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2021-12-03T10:32:10.000Z

FDA approval of subcutaneous daratumumab, carfilzomib, and dexamethasone for R/R MM

Dec 3, 2021
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On November 30, 2021, it was announced that the U.S. Food and Drug Administration (FDA) approved the use of subcutaneous daratumumab (daratumumab + hyaluronidase-fihj) in combination with carfilzomib and dexamethasone (Dara-Kd) for the treatment of adult patients with relapsed/refractory multiple myeloma (R/R MM) with ≤3 prior lines of therapy. The decision was based on results of a single cohort of patients in the ongoing PLEIADES trial (NCT03412565).1

PLEIADES trial1,2

  • A phase II, multicenter, multicohort study investigating the use of subcutaneous daratumumab in combination with standard MM treatment regimens
  • Trial start date: April 26, 2018
  • Primary completion date: August 12, 2020
  • Estimated end date: June 7, 2022
  • Enrollment in Dara-Kd cohort: adult patients with R/R MM with ≤3 prior lines of therapy (n = 66)
  • Primary outcome measure: overall response rate defined as the percentage of patients who achieve partial response or better based on the International Myeloma Working Group criteria

Results1

  • Overall response rate: 84.8% (95% confidence interval, 73.9–92.5%)
  • With a median follow-up of 9.2 months, the median duration of response had not yet been reached
    • Approximately 85.2% of patients maintained a response for ≥6 months
    • 82.5% of patients maintained a response for ≥9 months
  • The most common adverse reactions occurring in ≥20% of patients were upper respiratory tract infections, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and peripheral edema

Recommended dosing regimen1

Subcutaneous daratumumab (1,800 mg/30,000 units daratumumab/hyaluronidase) and dexamethasone are administered as per standard dosing.

The recommended dosing of carfilzomib intravenously over 30 minutes in each 28-day cycle is:

  • Once weekly:
    • 20 mg/m2 on Cycle 1 Day 1, and if tolerated 70 mg/m2 on Days 8 and 15
    • Then 70 mg/m2 on Days 1, 8, and 15 for Cycle 2 onwards
  • Or twice weekly:
    • 20 mg/m2 on Cycle 1 Days 1 and 2, and if tolerated 56 mg/m2 on Days 8, 9, 15, and 16
    • Then 56 mg/m2 on Days 1, 2, 8, 9, 15, and 16 for Cycle 2 onwards

  1. U.S. Food and Drug Administration. FDA approves Darzalex Faspro, Kyprolis, and dexamethasone for multiple myeloma. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darzalex-faspro-kyprolis-and-dexamethasone-multiple-myeloma. Published Dec 1, 2021. Accessed Dec 2, 2021.
  2. ClinicalTrials.gov. A study to evaluate subcutaneous daratumumab in combination with standard multiple myeloma treatment regimens. https://www.clinicaltrials.gov/ct2/show/NCT03412565. Updated Nov 5, 2021. Accessed Dec 2, 2021.

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