Karyopharm Therapeutics (NASDAQ:KPTI) reported positive topline results from its Phase 3 BOSTON study in patients with multiple myeloma who have received one-to-three prior lines of therapy.
The study evaluated once-weekly XPOVIO, in combination with once-weekly Velcade and low-dose dexamethasone, compared to standard twice-weekly Velcade and low-dose dexamethasone.
The study met its primary endpoint of a statistically significant increase in progression-free survival, which was 47% higher in patients receiving XPOVIO than in patients receiving standard therapy.
In July 2019, XPOVIO was approved for relapsed or refractory multiple myeloma under the FDA’s accelerated approval program based on the drug’s response rate. Karyopharm plans to submit data from this latest study to serve as a confirmatory trial.
“We are thrilled to report these highly significant topline results from the BOSTON study, the first randomized Phase 3 trial to demonstrate clinically and statistically significant activity of once-weekly XPOVIO in combination with a current standard-of-care treatment in patients with myeloma after one to three prior therapies,” Sharon Shacham, Karopharm’s president and CSO, said in a statement.
“We also intend to submit these data as quickly as possible to the FDA as part of a supplemental NDA seeking to expand the approved indication for XPOVIO into second-line treatment for patients with relapsed or refractory multiple myeloma,” she added.
