Physician Views: How do oncologists expect use of Kyprolis will be affected by Amgen's positive ASPIRE data?

Physician Views: How do oncologists expect use of Kyprolis will be affected by Amgen's positive ASPIRE data?

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Published on Aug 14, 2014

When Amgen paid $10.4 billion for Onyx Pharmaceuticals last fall it did so based on the belief that several ongoing studies would generate the data needed to expand use of Kyprolis into earlier stage multiple myeloma patients, thus greatly multiplying the drug's commercial potential.

In the three quarters since the deal closed, investors have put up with relatively unremarkable sales growth for Kyprolis but have been getting antsy waiting for the all-important readouts, which will likely dictate whether the acquisition is ultimately judged to be a bust.

Last week Kyprolis succeeded in the first of these trials, which brought sighs of relief rather than shouts of excitement from analysts who had been suggesting the drug's prospects - not to mention the credibility of Amgen's management - may be on the line.

Results from the Phase III ASPIRE study showed Kyprolis significantly extended progression-free survival as an add-on to Revlimid and dexamethasone by 8.7 months vs. the doublet alone, raising some interesting questions about where the drug goes from here as its path to blockbuster status is neither straight forward nor assured.

Amgen's first task is to submit the Phase III (ASPIRE) data to regulatory authorities, which it is expected to do in 1Q15 with an eye on receiving an initial approval of Kyprolis in Europe and extending the drug's label in the US beyond third-line use.

In the meantime, however, FirstWord asked oncologists in the US and EU5 for their perspective on the ASPIRE results, and in particular how the data might change what they decide to reach for in earlier lines of MM therapy - particularly in the second-line setting where Kyprolis and Celgene's Pomalyst are both vying for scrips.

Among Amgen's other ongoing studies of Kyprolis is the FOCUS trial in third-line or later therapy, where analysts suggest expectations have all but bottomed out already in part because of the difficulty in demonstrating a survival benefit in this population. Results are anticipated next quarter.

With that in mind, the questions we are asking physicians are...
  • How would you describe new interim data for the combination of Kyprolis (carfilzomib) and Revlimid (lenalidomide) for the treatment of relapsed multiple myeloma from the ASPIRE study?
  • Based on these data (and assuming approval), in what line of therapy would you expect to use the combination of Kyprolis and Revlimid most frequently?
  • To what percentage of total relapsed multiple myeloma patients would you expect to prescribe the combination of Kyprolis and Revlimid 12 months post approval?
  • What impact would you expect these data - if supportive of approval - to have on your current usage of Pomalyst (i.e. 12 months post approval for Kyprolis/Revlimid combo)?
  • If Kyprolis fails to demonstrate a statistically significant overall survival benefit in the ongoing FOCUS study (where it is being tested as part of third-or-later line therapy) how much more likely would you be to use Celgene's Pomalyst in the second-line setting?