Blood-cancer drug Kyprolis outperformed standard treatment in a late-stage trial testing the drug in patients with multiple myeloma, said Amgen, a result that fueled the biotech’s oncology aspirations.
The cohort in the Phase-III trial, called ASPIRE, included patients with multiple myeloma who have relapsed after treatment with one to three prior regimens. Subjects who took Kyprolis (carfilzomib) along with the standard therapy, Celgene’s Revlimid, tacked on 8.7 months of progression-free survival (PFS), meeting the primary endpoint of the trial.
Amgen said this data will form the basis of worldwide applications to market the drug, presumably for second-line multiple myeloma therapy, in the first half of next year.
Kyprolis, an injection, was approved by the FDA in 2012 as a third-line defense for patients who have failed to respond to at least two other therapies and have had their condition progress within 60 days of their last treatment.
The drug then became the centerpiece of Amgen’s $10.4-billion purchase of Onyx in 2013, a bet that the big biotech could reap Kyprolis’s potential by expanding it into earlier lines of therapy.
Amgen noted today that the data for overall survival (OS), a secondary endpoint of the ASPIRE trial, is not yet mature, but at time of analysis did not reach statistical significance.
Still, the PFS improvement of 8.7 months “is encouraging,” wrote Jefferies analyst Eun Yang in an investor note today, adding that she had expected at least six months. “PFS improvement of ~8-9 mo could lead to potential OS benefits per our prior expert discussion. This would likely secure label expansion of Kyprolis beyond current” relapsed/refractory multiple myeloma.
Yang held by her earlier Kyprolis sales forecast: $309 million this year, rising to $1.27 billion in 2018, vs. Street consensus of $669 million and $1.53 billion, respectively.