Amgen cancer drug fails key test
pharmafile | August 14, 2014 | News story | Sales and Marketing | Amgen, Cancer, Kyprolis, myeloma
Amgen’s new rare cancer drug has failed in a late-stage trial just a year after the US biotech spent $10.4 billion to acquire its manufacturer.
Kyprolis (carfilzomib), a proteasome inhibitor, is already approved in the US for the treatment of patients with multiple myeloma who have received at least two prior therapies, including Takeda’s Velcade (bortezomib) and an immunomodulatory agent.
This effectively makes it a third-line treatment, and the new Phase III study was looking to see whether it could work on improving survival for late-stage patients – potentially pushing it up the treatment pathway.
But data published this week show the drug failed to improve overall survival when compared to patients using a low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide in patients with relapsed and advanced refractory multiple myeloma.
There was also an increase in the incidence of renal adverse events for those patients taking Kyprolis, compared to those who were not.
This study, known as Focus, was intended to show that the drug helped patients live longer, something that European regulators usually require before approving a treatment. The drug has not yet been approved by the EMA.
“The negative results commercialisation of this drug in earlier lines of myeloma, as well as other indications raise questions about the future development,” Sanford Bernstein analyst Geoffrey Porges said in a research note.
Amgen took on the drug when it bought its original developer Onyx this time last year in a deal worth $10.4 billion. Kyprolis was seen as being the key to this deal, and the latest data will indeed be a blow for both firms.
Onyx has global rights outside Japan for the product, which has orphan drug designation in the US with exclusivity until July 2019, and patents extending until at least 2025.
Analysts predict it could make $3 billion a year by 2021, but this could well be hampered by these latest results.
There are a number of targeted multiple myeloma drugs on the market, including Celgene’s Revlimid (lenalidomide) and next gen drug Thalidomide, as well as Takeda’s Velcade.
Analysts expect the multiple myeloma market to reach $5.4 billion by 2016, with Kyprolis expected to take around $600 million of that.
Survival gains
Pablo Cagnoni, president of Onyx Pharmaceuticals, says that while it is ‘unfortunate’ that the study did not meet its primary endpoint, he still believes the results from another Phase III study known as Aspire will be good enough to support regulatory submissions around the world.
This trial showed that Kyprolis, in combination with Revlimid and a corticosteroid, helped patients live 8.7 months longer without their disease worsening (known as progression-free survival) compared to Revlimid and the corticosteroid alone.
But the Focus study measured the more important endpoint of overall survival, something that regulators favour more over PFS, meaning Aspire may not be good enough to warrant licence extensions, therefore putting a halt on extra revenue.
Ben Adams
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