Selinexor extends PFS in advanced endometrial cancer
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Selinexor prolonged PFS compared with placebo among women with advanced or recurrent endometrial cancer, according to topline data released by the agent’s manufacturer.
The therapy also appeared well-tolerated, results of the randomized phase 3 SIENDO study showed.
Selinexor (Xpovio; Karyopharm Therapeutics) is an oral selective inhibitor of nuclear export compound. The drug binds with and inhibits the nuclear export protein XPO1, leading to the accumulation of tumor suppressor proteins in the cell nucleus.
Selinexor is approved in the United States for multiple oncology indications, including treatment of specific patients with multiple myeloma and diffuse large B-cell lymphoma.
The multicenter, blinded SIENDO study included 263 women with stage IV or recurrent endometrial cancer who achieved partial or complete response after at least 12 weeks of standard taxane-platinum combination chemotherapy.
Researchers assigned women 2:1 to maintenance therapy with 80 mg selinexor once weekly or placebo until disease progression. PFS served as the primary endpoint.
Results showed statistically significant improvement in median PFS within the selinexor group (5.7 months vs. 3.8 months; HR = 0.7; P = .0486).
Researchers also reported significantly improved median PFS in the prespecified subgroup of women with p53 wild-type disease (13.7 months vs. 3.7 months; HR = 0.38; P = .0006).
Investigators reported no new safety signals with selinexor, with 10.5% of patients discontinuing treatment due to adverse events.
Karyopharm Therapeutics officials intend to submit a supplemental new drug application to the FDA and present complete results of the SIENDO study in the first half of this year.
“Women with advanced or recurrent endometrial cancer face a poor prognosis," principal investigator Vicky Makker, MD, medical oncologist at Memorial Sloan Kettering Cancer Center, said in a Karyopharm Therapeutics-issued press release. “Following standard of care, platinum-based chemotherapy, the current paradigm of watchful waiting for recurrence is simply inadequate. Therefore, there is a dire need for new and innovative treatment options for this heterogeneous malignancy that is rising in incidence and disease-related mortality.”
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