Karyopharm Therapeutics (NASDAQ:KPTI) announces detailed results from a Phase 3 clinical trial, BOSTON,
evaluating Xpovio (selinexor), combined with Takeda’s Velcade
(bortezomib) and low-dose dexamethasone, in multiple myeloma patients
who had received one-to-three prior lines of therapy. The data will be
virtually presented tomorrow at the ASCO Scientific Program.
The selinexor triplet therapy, dosed weekly,
resulted in a 47% increase in median progression-free survival (PFS)
compared to Velcade + dexamethasone (Vd) dosed twice weekly. The effect
was consistent across a range of patient subgroups such as those
previously treated with lenalidomide (Bristol Myers Squibb’s Revlimid)
and those with high-risk chromosomal profiles. Specifically, median PFS
in the selinexor arm was 13.9 months versus 9.5 months in the Vd arm
(p=0.0075).
The overall response rate in the selinexor arm was also superior to the Vd arm (76.4% vs. 62.3%; p=0.0012).
Median overall survival (OS) in the selinexor arm was not reached at data cutoff. Median OS in the Vd arm was 25.0 months.
On the safety front, the rate of peripheral neuropathy was lower in the selinexor arm (32.3% vs. 47.1%; p=0.0010).
The company has submitted a supplemental marketing
application to the FDA for the triplet therapy in treatment-experienced
multiple myeloma patients. It expects to file an application in Europe
later this year.
Shares up 6% after hours.
https://seekingalpha.com/news/3578444-karyopharm-up-6-on-late-stage-selinexor-data-in-multiple-myeloma
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.