Amgen multiple myeloma drug Kyprolis has struggled for years to live up to expectations, and competition's only getting fiercer. But the company is hoping a new, more convenient dosing regimen—backed by convincing data—will help do the trick.
The Big Biotech has submitted a once-weekly version of the drug to the FDA, aiming for a combination approval, alongside the steroid dexamethasone, for patients whose disease has either relapsed or grown treatment-resistant. In a head-to-head phase 3 against the original—dubbed Arrow—the once-weekly Kd combo kept disease at bay for a median 11.2 months, compared with just 7.6 months for the older formulation. The new combo also beat its predecessor on response rates, with an overall rate of 62.9% compared with just 40.8% for the original formula.
The data illustrate “Kyprolis’ potential to extend the time patients live without their disease progressing while also providing a more convenient … dosing option for this frequently relapsing and difficult-to-treat cancer,” David Reese, Amgen’s EVP of R&D, said in a statement, adding that he was proud of a Kyprolis clinical program that has put “a focus on generating additional data to reduce the dosing and administration burden on patients.”
Not all of Kyprolis’ recent clinical trial performances have been as sunny, however. In 2016, the drug’s growth prospects took a hit when a combination of Kyprolis, melphalan and prednisone failed to top a cocktail of melphalan, prednisone and Johnson & Johnson and Takeda’s Velcade at improving survival among previously untreated patients.
A first-line nod would have bolstered Kyprolis' sales, which amounted to just $263 million worldwide in the second quarter—leaving the drug far off the $2.4 billion mark analysts once forecast for 2019, along with the $3 billion in peak sales some industry watchers predicted after the product's hot start.
Amgen could use a sales bump, too, with biosimilars makers coming after its old stalwarts Neupogen and Neulasta. And Neulasta copycat Mylan isn't messing around, either; It has well undercut Amgen on price in hopes of stealing share, and fast. Analysts have even gone so far as to suggest that Amgen buy up rare-disease specialist Alexion to cope with the losses.
So far, the Kd pairing has come through for Amgen, which shelled out $10 billion on Kyprolis-maker Onyx back in 2013. Earlier this year, the FDA added data to Kyprolis’ label showing that Kd could top a Velcade-dexamethasone pairing, an industry standard, at cutting patients’ risk of death.
With its long-acting Kyprolis submission to the FDA, Amgen is hoping it can keep the regulatory stream of good news coming, and it may not have to wait that long to find out. The agency is reviewing the company’s application under its Real-Time Oncology Review pilot program, which aims “to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible,” Amgen said.