Karyopharm Therapeutics Inc (Nasdaq:KPTI), a commercial-stage pharmaceutical company developing novel cancer therapies, on Thursday announced topline results from its Phase 3 XPORT-EC-042 trial evaluating XPOVIO (selinexor) as a maintenance-only therapy compared to placebo in adult patients with TP53 wild-type advanced or recurrent endometrial cancer.

The trial did not meet its primary endpoint of progression free survival (PFS). A trend favouring the selinexor arm was observed in the modified intent to treat (mITT) population, with a median PFS of 12.75 months in the selinexor arm compared to 7.43 months in the placebo arm. The safety and tolerability profile of selinexor was consistent with its established safety profile, with no new safety signals observed.

"These results are meaningful for a patient population lacking effective maintenance therapies that can delay disease progression," commented Professor Ignace Vergote, MD, gynaecologic oncologist at the Catholic University Leuven in Belgium, European Network for Gynaecological Oncological Trial groups (ENGOT) and global lead principal investigator. "The trend for a longer progression-free survival observed in the mITT population of the selinexor arm continues to highlight the potential of XPO1 inhibition in patients with TP53 wild-type/pMMR endometrial cancer."

Karyopharm said that it intends to complete a full evaluation of the data from the XPORT-EC-042 trial and plans to present the data at a future medical meeting. The results of the XPORT-EC-042 trial do not affect ongoing trials of selinexor in other potential indications.

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor compound for the treatment of cancer. It functions by selectively binding to and inhibiting the nuclear export protein XPO1.