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FDA Approval for Relapsed or Refractory Multiple Myeloma
March 2022: Daratumumab + hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) and carfilzomib (Kyprolis, Amgen, Inc.) plus dexamethasone have been approved by the Food and Drug Administration for adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
PLEIADES (NCT03412565), a multi-cohort, open-label trial, was used to assess efficacy in a single-arm cohort. 66 individuals with relapsed or refractory multiple myeloma who had undergone at least one prior line of therapy were included in this study. Darzalex Faspro 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) was given subcutaneously in combination with Kyprolis (20/70 mg/m2 once weekly regimen) and dexamethasone to the patients.
Efficacy Results: Response Rates and Duration
The overall response rate was the primary efficacy outcome measure (ORR). The ORR for this study was 84.8 percent (95 percent CI: 73.9 percent , 92.5 percent ). The median length of response had not been attained at a median follow-up of 9.2 months, but an estimated 85.2 percent (95 percent CI: 72.5, 92.3) maintained response for at least 6 months and 82.5 percent (95 percent CI: 68.9, 90.6) maintained response for at least 9 months.
Upper respiratory tract infections, fatigue, insomnia, hypertension, diarrhoea, cough, dyspnea, headache, pyrexia, nausea, and edoema peripheral were the most prevalent side events (20%) in patients treated with Darzalex Faspro, Kyprolis, and dexamethasone.
Recommended Dosage and Administration
Darzalex Faspro is administered subcutaneously at a dose of 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) once weekly from Weeks 1 to 8, once every 2 weeks from Weeks 9 to 24, and once every 4 weeks starting Week 25 until disease progression or intolerable toxicity.
The recommended dosage regimens of Kyprolis when administered in combination with Darzalex Faspro are the following:
Once weekly 20/70 mg/m2 regimen: Kyprolis 20 mg/m2 administered by IV infusion over 30 minutes on Cycle 1 Day 1 and if a dose of 20 mg/m2 is tolerated, 70 mg/m2 as a 30-minute IV infusion on Cycle 1, Day 8 and Day 15, and then Day 1, 8, and 15 of each 28-day cycle.
Twice weekly 20/56 mg/m2 regimen: Kyprolis 20 mg/m2 administered by IV infusion over 30 minutes on Cycle 1 Day 1 and Day 2 and, if a dose of 20 mg/m2 is tolerated, 56 mg/m2 administered by IV infusion over 30 minutes on Cycle 1, Day 8, 9, 15, and 16, and then on Day 1, 2, 8, 9, 15, 16 of each 28-day cycle.
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About Susan Hau
Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy. Hau's expertise lies in cancer cell biolo…
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