Amgen's Kyprolis fails in first-line myeloma
- Amgen reported Tuesday morning its Phase 3 trial of Kyprolis (carfilzomib) plus melphalan and prednisone (KMP) failed to hit its primary endpoints in first-line treatment of multiple myeloma patients when compared with Takeda's Velcade (bortezomib) plus melphalan and prednisone (VMP).
- Interim data showed Kyprolis achieved a progression-free survival (PFS) of 22.3 months, compared to 22.1 months for patients on the Velcade regimen – a difference which was not statically significant.
- Overall survival (OS) data from the trial is "not yet mature," Amgen said in a statement, but the hazard ratio is 1.21. Evercore ISI analyst John Scotti indicated in a note to investors that the OS data is "trending in the wrong direction."
Amgen, which is trying to build out its Kyprolis franchise, called the data disappointing. Yet, the company pointed out on a conference call and in its statement that melphalan and prednisone regimens are typically not used anymore. The trial had been designed before this shift in treatment occurred.
Kyprolis brought in $172 million worldwide during the second quarter and Amgen is currently in discussions to test the drug in combination with Johnson & Johnson's Darzalex. The company said on the call that those discussions "are quite far down the road."
"Investors have been tempering their outyear expectations for Kyprolis after impressive data in the second-line setting from daratumumab [J&J's Darzalex], and in advance of Velcade going generic in 2017, and it’s likely that cooling of the ~$2.3 billion in consensus peak sales (~9% of AMGN’s outyear revenues) will continue after today’s result," wrote Scotti.
The Kyprolis arm of the study showed a similar safety profile to previous studies. Yet, the incidence of fatal adverse events were higher in the Kyprolis arm compared with those on the Velcade regimen: 6.5% vs. 4.3%, respectively.
- Amgen Statement
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