FDA approves Darzalex-based regimen for relapsed, refractory multiple myeloma
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The FDA approved daratumumab for use combined with carfilzomib and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy, according to a press release.
Daratumumab (Darzalex, Janssen), an anti-CD38 therapy, is approved for use with carfilzomib in two dosing regimens — 70 mg/m2 once weekly or 56 mg/m2 twice weekly.
The FDA based this approval, in part, on data from the phase 3 CANDOR trial, which evaluated the addition of daratumumab to twice-weekly carfilzomib (Kyprolis, Amgen) and dexamethasone among 466 patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy.
Results showed the combination prolonged median PFS, the study’s primary endpoint, compared with carfilzomib and dexamethasone alone (not reached vs. 15.8 months; HR = 0.63; 95% CI, 0.46-0.85).
Serious adverse events occurred among 56% of patients who received the daratumumab regimen compared with 46% of patients who received carfilzomib and dexamethasone alone. The most common of these was pneumonia (14% vs. 9%).
Data from the open-label, multicohort phase 1b EQUULEUS trial served as the basis for the approval with the once-weekly carfilzomib dose. That study, which is evaluating the combination of daratumumab with various other treatments, showed positive results with the daratumumab-carfilzomib-dexamethasone combination.
“The significant increase in PFS seen among patients receiving the [daratumumab-carfilzomib-dexamethasone] regimen supports the use of this new combination for patients with relapsed and refractory multiple myeloma. We continue to advance effective regimens for the most critical patients who have already relapsed,” Saad Z. Usmani, MD, FACP, division chief of plasma cell disorders at Levine Cancer Institute at Atrium Health, principal investigator of the CANDOR study, and a HemOnc Today Editorial Board Member, said in the release. “The [daratumumab-carfilzomib-dexamethasone] regimen fills an important gap in the treatment landscape, as many patients may relapse following an immunomodulatory drug-based therapy, such as lenalidomide [Revlimid, Celgene]-containing regimens, and therefore new therapeutic options are needed.”
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