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Amgen hit as Kyprolis fails myeloma study

Inability to improve overall survival could dent expanded use prospects
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Amgen's chances of expanding the market for its multiple myeloma drug Kyprolis have been dented after the drug failed to meet its objectives in a phase III trial.

The company's Onyx Pharmaceuticals subsidiary revealed yesterday that Kyprolis (carfilzomib) was unable to improve overall survival in the FOCUS study, which compared the drug to steroid therapy and cyclophosphamide in 315 patients with relapsed and advanced refractory myeloma.

All the patients in the study had received extensive earlier treatment for the cancer, according to Amgen, which had hoped to use the trial to support an extension of Kyprolis' labelling to include second-line as well as its current third-line indication in myeloma.

The results come just days after Amgen and Onyx revealed interim data from the ASPIRE study which showed that Kyprolis extended progression-free survival (PFS) when added to a regimen of Celgene's Revlimid (lenalidomide) and dexamethasone. That study also showed a tendency to improve overall survival with Kyprolis, prompting Amgen to speculate about a possible filing of the drug for second-line use in the first half of 2015.

Amgen and Onyx put a brave face on the FOCUS findings, saying: “We believe the results from the recent positive ASPIRE phase 3 clinical trial will be sufficient to support regulatory submissions around the world.”

Kyprolis was one of the drivers behind Amgen's $10.4bn acquisition of Onyx last year and has been growing steadily since its launch in 2012, with sales of $146m in the first six months of the year, almost entirely coming from the US market.

The long-term sales potential of Kyprolis – which some analysts have put as high as $2bn a year at peak - 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.

Amgen is carrying out a trial of first-line Kyprolis called CLARION, and is also developing a once-weekly formulation of the drug to sit alongside the current twice-weekly version.

Amgen's takeover of Onyx was reportedly held up by requests to look at data on Kyprolis, particularly relating to studies supporting its marketing application in Europe.

Aranesp recall

Separately, Amgen also announced a recall of a number of pre-filled syringes of its anaemia drug Aranesp (darbepoetin alfa), after particles of what is believed to be cellulose and/or polyester were detected.

Nine lots of the drug are being recalled as a precautionary measure, the company said.

Article by
Phil Taylor

14th August 2014

From: Research

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