Building on an upbeat side effect profile for carfilzomib, Onyx Pharma has laid out a promising set of extended survival data on the experimental cancer therapy. Yesterday the biotech company noted that in a Phase IIb study the drug did not spur peripheral neuropathy in patients, a common side effect seen with drugs now in use for advanced multiple myeloma. Today researchers added that the drug extended survival to 15.5 months and the news swiftly boosted its shares by 18 percent.
That survival rate "compared favorably to what one would expect, which is less than nine months in this patient population," Onyx Chief Medical Officer Michael Kauffman told Reuters. The study involved 266 cancer patients with treatment-resistant cases of multiple myeloma. In a subset analysis, the biotech noted that 19 percent of patients who had failed Velcade responded to carfilzomib. Onyx plans to file for an FDA approval in the middle of next year.
"In our view, this exceeds expectations, and it's also notable that these results were generated with what looks like a low dose of carfilzomib (probably the lowest effective dose)," JP Morgan analyst Corey Kasimov said in a research note.
"There is a significant need for new treatment options for these patients with refractory multiple myeloma who have exhausted all other options," said Dr. David Siegel. "This heavily pretreated patient population has received all classes of approved and commonly used myeloma therapies, and the durable responses and tolerability demonstrate carfilzomib's potential as a promising treatment."
- check out the Onyx release
- here's the AP report
- read the Reuters story