KYPROLIS is an Amgen product that utilizes Captisol® in its formulation
Approval based on the CANDOR and EQUULEUS Studies
Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) announces that a major Captisol customer Amgen (NASDAQ:AMGN) has received U.S. Food and Drug Administration (FDA) approval for the expansion of the KYPROLIS® (carfilzomib) U.S. prescribing information to include its use in combination with DARZALEX® (daratumumab) plus dexamethasone (DKd) in once- and twice-weekly dosing regimens for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM) who have received one to three previous lines of therapy.
"We are proud of the ongoing work by Amgen to expand the use of KYPROLIS in combination with other therapies. This FDA approval came earlier than we had anticipated and allows for KYPROLIS to be used with DARZALEX and dexamethasone in patients in the U.S. with an incurable type of blood cancer," said John Higgins, Chief Executive Officer of Ligand. "We are very pleased with the impact that Captisol-enabled medicines are having to-date in 2020 for the treatment of multiple serious diseases, including relapsed/refractory multiple myeloma and COVID-19."
The CANDOR trial was the first Phase 3 randomized trial to compare DKd versus KYPROLIS and dexamethasone (Kd) alone in R/R MM patients. The study met its primary endpoint and resulted in a 37% reduction in the risk of disease progression or death in patients receiving DKd (HR=0.63; 95% CI: 0.464, 0.854; 1-sided p-value=0.0014) compared to Kd alone.
In CANDOR, the safety of DKd was generally consistent with the known safety profiles of the individual agents. The most frequently reported (≥ 20% of subjects in either the DKd or Kd treatment arm) treatment-emergent adverse events (AEs) included infusion-related reactions, anemia, diarrhea, fatigue, hypertension, pyrexia, upper respiratory tract infection, thrombocytopenia, neutropenia, lymphopenia, cough, dyspnea and insomnia, headache and back pain. The incidence of treatment-emergent Grade 3 or higher, serious and fatal AEs was higher in the DKd arm compared to the Kd arm. The most common reason for fatal treatment-emergent AEs in both arms was infection. The rate of treatment discontinuation due to AEs was similar in both arms.
The expansion of KYPROLIS's prescribing information to include once-weekly dosing of KYPROLIS within the DKd regimen was supported by the open-label, multi-cohort Phase 1b EQUULEUS trial, in which the safety and efficacy of DKd was assessed among R/R MM patients using a once-weekly dosing regimen for KYPROLIS.
Amgen has submitted additional marketing applications globally.
DARZALEX® is a registered trademark of Janssen Pharmaceutica NV.