Dive Brief:
- 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."
Dive Insight:
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.