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Amgen’s Kyprolis disappoints in Phase III trial

pharmafile | September 27, 2016 | News story | Manufacturing and Production, Research and Development Amgen, Kyprolis, phase III 

Amgen was relying on the results of the trial to justify its $10.4 billion purchase of Onyx Pharmaceuticals, acquiring Kyprolis at the same time, and needed strong data in terms of progression-free survival. However, the actual results suggested that the median PFS was 22.3 months for the Kyprolis arm against 22.1 months for the Velcade cohort. Sean Harper, head of R&D at Amgen, said in a statement: “The Clarion results…are disappointing, especially given the robust data we’ve seen in the second-line setting.”

The second line data regarding a Kyprolis-based regimen found a PFS of 18.7 months compared with a 9.4 months for the Velcade regimen. These impressive statistics had led to a belief that they could bolster Kyprolis’ disappointing sales, at $512 million in 2015, and $326 million in the first half of 2016. With the release of the Phase III trial and the multiple myeloma market becoming incredibly competitive, with rival products from Celgene, Takeda, Johnson & Johnson, AbbVie and Bristol-Myers Squibb all on the market.

Amgen will now continue Phase III trials with Kyprolis used in conjunction with other drugs to reassert the possibility of its strengths over Velcade.

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Ben Hargreaves

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