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Amgen builds case for bigger Kyprolis market with impressive second-line data

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Amgen ($AMGN) just totted up some data that could beef up sales of Kyprolis, its multiple myeloma drug that's going toe-to-toe with Celgene's ($CELG) Pomalyst. Amgen put out the word Monday that adding Kyprolis to combo therapy with Celgene's Revlimid beat out the Revlimid combo alone in melanoma patients who had relapsed.

The Phase III data could tip the scales toward second-line use of Kyprolis--in patients who've relapsed after one round of drug therapy. Right now, Kyprolis is only FDA-approved as a third-line treatment, which means patients have to relapse twice before they're eligible for the Amgen drug. That's a much smaller market than the second-line group.

Winning the chance to treat patients earlier on in the disease is key to Amgen's blockbuster hopes for Kyprolis. It's so important that the Big Biotech demanded more data on the potential indication when it was negotiating to buy Onyx Pharmaceuticals, which developed the drug, last year. So far, Kyprolis has faced a tough battle with Pomalyst, its head-to-head competition in the third-line treatment area.

The headline numbers from the new study included a 26.3-month median for disease-free progression for the Kyprolis group, compared with 17.6 months for the Revlimid-only arm. That may be good enough for an accelerated approval for the expanded patient population, according to Amgen. The full slate of data will be reviewed at the American Society of Hematology later in the year. Amgen shares spiked about 4% in premarket trading.

There was a big hitch, though. Investigators say that while data for a key secondary endpoint on overall survival had not fully matured, the trend favored the Kyprolis/Revlimid combo but did not achieve statistical significance, leaving no clear evidence of a survival benefit.

Still, the improvement in progression-free survival was impressive, and staving off relapse is the name of the game in myeloma. The Kyprolis results mark another step down a path that could make myeloma into a disease that can be managed indefinitely, trial investigators said.

"In the treatment of patients with multiple myeloma, periods of remission become shorter following each treatment regimen, underscoring the need for new options," said Dr. Pablo Cagnoni, president of Onyx Pharmaceuticals. "The ability of novel therapies to produce deep and durable responses may, one day, transform this uniformly fatal disease to one that is chronic and manageable."

Amgen spent $10.4 billion to pick up Onyx--and Kyprolis (carfilzomib)--last year. With the deal, Amgen hoped to add to its efforts toward an oncology franchise. That's a key part of the company's late-stage pipeline effort, which includes a pair of recent FDA applications and now a major retrenchment in R&D as Amgen shutters its R&D hub in Seattle and cuts up to 2,900 staffers.

- here's the release

Special Report: Top 15 Drug Launch Superstars - Kyprolis - Onyx Pharmaceuticals

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