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 Kyprolis, the centerpiece of Amgen's nearly $10 billion acquisition
of Onyx Pharmaceuticals in 2013, had sales last year of $331
million. Velcade, sold by Takeda Pharmaceutical Co and Johnson &
Johnson, had 2014 sales of nearly $3 billion.
The interim look showed that patients with relapsed multiple myeloma
treated with Kyprolis and chemotherapy dexamethasone lived for a
median of 18.7 months before their disease worsened, compared with
9.4 months for patients treated with Velcade and the chemotherapy
drug.
Amgen said the study has yet to show a difference in survival
between the two groups, but said it did demonstrate superiority for
Kyprolis in secondary goals of higher overall response rate and
lower incidence of nerve pain.
Sean Harper, Amgen's head of research and development, said the
study will continue until overall survival can be determined.
"This was the bet we made when we acquired Onyx," he said. "To be
able to demonstrate something compelling enough with respect to the
difference between Kyprolis and Velcade," which will lose U.S.
patent protection in 2017.
Rates of cardiac failure and kidney failure for Kyprolis were higher
than for patients treated with Velcade. There was also an increase
in the incidence of hypertension and shortness of breath in the
Kyprolis group compared to Velcade.
The U.S. Food and Drug Administration, in 2012, granted Kyprolis
accelerated approval for use in multiple myeloma, the second most
common form of blood cancer, after prior therapies stopped working.
The Amgen drug has a wholesale price of over $10,000 a month.
Amgen filed earlier this year for FDA approval of Kyprolis as a
second-line myeloma treatment based on positive results from a study
comparing the drug in combination with dexamethasone and Celgene
Corp's Revlimid, to a regimen containing just Revlimid and the
chemotherapy drug.
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Results from a head-to-head trial comparing Kyprolis to Velcade in
newly diagnosed multiple myeloma patients are likely to come in
2016, Harper said.
Takeda has announced positive results from a trial of its oral
version of Velcade, which like Kyprolis, must be given by infusion.
Harper said Amgen expects that oral drugs in this class, proteosome
inhibitors, will likely be used as "maintenance" treatments for
myeloma patients whose disease is first controlled by existing,
infused drugs.
"Demonstrating superiority over Velcade in this head-to-head trial
supports our goal of ensuring continued improvement of patient
outcomes and potentially establishing Kyprolis as the backbone of
therapy for patients with multiple myeloma," Pablo Cagnoni,
president of Amgen's Onyx unit, said in a statement.
(Reporting by Deena Beasley in Los Angeles; Editing by Eric Walsh)
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