J&J adds yet another multiple myeloma regimen to the Darzalex label as Sanofi rival jumps in
J&J’s third-line multiple myeloma blockbuster Darzalex got the FDA green light for a new regimen to take another swing at the blood cancer — this time, in a cocktail with carfilzomib and dexamethasone.
The combination therapy was approved to treat relapsed or refractory multiple myeloma patients who have already received one to three lines of treatment.
Darzalex, a CD38-directed antibody, led the market for years after its approval in 2015 for third-line multiple myeloma patients. But this year, it faces competition from Sanofi’s Sarclisa, another CD38-targeting drug approved in April as a third-line treatment for multiple myeloma patients, in combination with pomalidomide and dexamethasone.
In a Phase III study — dubbed CANDOR — the Darzalex cocktail (DKd) met its primary endpoint in progression-free survival. The combination reduced patients’ risk of disease progression or death by 37%, compared to those only treated with carfilzomib and dexamethasone (Kd), according to J&J. The FDA also based its approval on results from EQUULEUS, a Phase Ib study that examined safety, tolerability and a dosing regimen.
Those who took the Sarclisa cocktail in a Phase III study had a median PFS of 11.5 months, compared with 6.5 months for those who took pomalidomide and dexamethasone alone.
“The significant increase in progression-free survival (PFS) seen among patients receiving the DKd 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 Usmani, Atrium Health’s Levine Cancer Institute division chief and principal CANDOR investigator, said in a statement.
“The DKd regimen fills an important gap in the treatment landscape, as many patients may relapse following an immunomodulatory drug-based therapy, such as lenalidomide-containing regimens, and therefore new therapeutic options are needed,” Usmani continued.
J&J inked a $1.1 billion agreement with Genmab to develop, manufacture and commercialize daratumumab (Darzalex) in 2012. It shelled out $55 million upfront, with tiered “double digit” royalties. In 2019, Darzalex raked in nearly $3 billion in sales.
“With this most recent approval of the DKd regimen, patients with multiple myeloma now have the option to receive treatment with DARZALEX and carfilzomib as early as their first relapse, which is a critical time in their treatment journey,” said Craig Tendler, Janssen’s VP of late development and global medical affairs, in a statement.