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Amgen's Kyprolis tops Velcade in myeloma trial

Amgen hoping to topple Takeda’s $2bn a year drug

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Amgen's myeloma therapy Kyprolis has outperformed rival drug Velcade from Takeda in a head-to-head study, setting up a marketing battle.

The ENDEAVOUR trial is one of two studies that Amgen is hoping will topple Velcade (bortezomib) from the top of the myeloma market and justify the $10.4bn it paid for Kyprolis' developer Onyx Pharmaceuticals in 2013.

ENDEAVOUR compared Kyprolis and Velcade in multiple myeloma patients who had failed at least one prior treatment, and an interim analysis has showed that those on Amgen's drug lived twice as long without their disease worsening (almost 19 months versus 9 months).

Kyprolis-treated patients also did better than those on Velcade on the secondary endpoints of higher overall response rate and lower neuropathy side effects. Overall survival data is not yet mature however and will be reported later.

The big test for Kyprolis will come with the results of the CLARION study comparing the drug Velcade in newly-diagnosed multiple myeloma patients, which represents a much larger target population.  The results of that study are due next year.

"We believe that Kyprolis is the best-in-class proteasome inhibitor and we're looking forward to seeing the results of these studies over time," said Sean Harper, Amgen's head of R&D, during the firm's recent' four-quarter results meeting.

Kyprolis has already made good headway in the myeloma market, adding more than $300m to Amgen's coffers last year up from $73m in 2013, but still has some way to go before it catches $2bn-a-year Velcade. 

Meanwhile, Amgen is still firming up Kyprolis' label in other areas. It recently filed for approval of the drug in relapsed multiple myeloma in both the EU and US based on the ASPIRE trial data, although a supportive study - called FOCUS - failed to show efficacy. 

The FDA approved Kyprolis in July 2012 for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent. The ASPIRE data will support its use as a second-line therapy in combination with chemotherapy.

The peak sales potential of Kyprolis – which has been put at $2bn a year or more by analysts - hinges on it moving upstream in myeloma treatment. The second-line treatment population is two or three times the size of third-line, while first-line use would once again expand the market opportunity two or three-fold.

Article by
Phil Taylor

2nd March 2015

From: Research, Sales

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