Biotech Values

[DewDiligence]

Kyprolis bests Velcade in phase-3 trial in second-line MM:

http://finance.yahoo.com/news/phase-3-head-head-endeavor-000000286.html

Amgen…today announced the results from a planned interim analysis showing that the Phase 3 head-to-head clinical trial ENDEAVOR evaluating Kyprolis (carfilzomib) for Injection in combination with low-dose dexamethasone versus Velcade (bortezomib) and low-dose dexamethasone met the primary endpoint of progression-free survival (PFS). Patients with relapsed multiple myeloma treated with Kyprolis lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over Velcade (median PFS 18.7 months versus 9.4 months, HR=0.53, 95 percent CI, 0.44 – 0.65).

The Kyprolis combination demonstrated superiority over the Velcade combination for secondary objectives of higher overall response rate and lower neuropathy events. Overall survival data are not yet mature and continue to be monitored.

Wow. When the upper bound of the 95% CI for the hazard ratio of the primary endpoint (PFS in this instance) is as low as 0.65, that’s a great outcome.

Detailed results will be presented at ASCO.