Back in March, Amgen’s Kyprolis posted new data showing it could top Takeda’s Velcade at extending survival. And now, the multiple myeloma-fighter has put up more survival results that will strengthen its case against its rivals.
In a phase 3 study, the Big Biotech’s med, in combination with Celgene’s Revlimid and chemo dexamethasone—a trio known as KRd for short—slashed the risk of death by 21% over Revlimid and dexamethasone alone. Median survival checked in at 48.3 months for the KRd trifecta, versus 40.4 months for the Rd duo.
KRd has had an FDA green light since July, 2015 thanks to positive progression-free survival data from this same trial, Aspire. In addition to extending progression-free survival to 26.3 months from 17.6 months, adding Kyprolis into the mix also took the study’s overall response rate to 87% from 67%.
With Wednesday’s data, though, “this Kyprolis regimen should be considered a new standard of care,” trial investigator David Siegel said in a statement.
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This survival boost—as well as the one the Endeavor study, the Kyprolis-Velcade showdown, provided in March—are plenty welcome for Amgen, which has been facing tough questions ever since shelling out $10 billion for Kyprolis maker Onyx in 2013. The med has struggled to live up to its billing, and a raft of new competitors—from Takeda, Johnson & Johnson and others—haven’t made that task any easier.
And then there’s the fact that a trial misfire may have nearly closed the door on Amgen’s chances for a first-line Kyprolis indication. Last September, the California drugmaker said that Kyprolis, combined with melphalan and prednisone, had failed to significantly top a cocktail of melphalan, prednisone and Johnson & Johnson and Takeda’s Velcade at improving progression-free survival or overall survival.
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Since then, Amgen has pointed to another first-line trial, and ongoing study at the ECOG-ACRIN Cancer Research Group pitting KRd against Rd in newly diagnosed patients. But the first flopped try “does not inspire confidence in that trial,” Evercore ISI analyst John Scotti wrote in at the time.