March 2, 2015 / 12:05 AM / 3 years ago

Amgen says Kyprolis doubles progression-free survival vs Velcade

(Reuters) - Amgen Inc’s Kyprolis helped patients with relapsed multiple myeloma live twice as long before their blood cancer worsened compared to a regimen containing rival drug Velcade, according to an interim analysis announced by the company on Sunday.

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.

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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