Karyopharm Announces FDA Discussions Regarding Selinexor's Endometrial Cancer Program
核心洞察
Karyopharm Therapeutics is engaging with the FDA to discuss the evolving treatment landscape in endometrial cancer (搜索) and its impact on the Phase 3 XPORT-EC-042 trial.
The XPORT-EC-042 trial is evaluating selinexor as maintenance therapy for TP53 (搜索) wild-type advanced or recurrent endometrial cancer (搜索) following systemic treatment.
Karyopharm has paused discussions on its endometrial cancer (搜索) program at the Piper Sandler conference, awaiting further clarity from the FDA interaction.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) announced that it is in discussions with the U.S. Food and Drug Administration (FDA) regarding its endometrial cancer (搜索) program, specifically concerning the Phase 3 XPORT-EC-042 trial and the evolving treatment landscape. The company expects to provide an update after the discussion with the FDA.
In light of these discussions, Karyopharm has decided not to present its endometrial cancer (搜索) program at the Piper Sandler 36th Annual Healthcare Conference. The focus remains on aligning the clinical development strategy with the FDA's perspective on the current treatment options and unmet needs in endometrial cancer.
XPORT-EC-042 Trial Details
The XPORT-EC-042 trial (NCT05611931) is a global, Phase 3, randomized, double-blind study assessing selinexor as a maintenance therapy in patients with TP53 (搜索) wild-type advanced or recurrent endometrial cancer (搜索) following systemic therapy. Initiated in November 2022, the trial aims to enroll up to 220 patients, randomized 1:1 to receive either 60 mg of oral selinexor once weekly or placebo until disease progression.
The primary endpoint of the study is progression-free survival (PFS), as assessed by the investigator. Overall survival (OS) is a key secondary endpoint. Karyopharm has partnered with Foundation Medicine, Inc. to develop FoundationOne®CDx, a tissue-based comprehensive genomic profiling test, to identify and enroll patients with TP53 (搜索) wild-type tumors.
About Selinexor
Selinexor, marketed as XPOVIO®, is a first-in-class, oral exportin 1 (XPO1 (搜索)) inhibitor and the first of Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds. It functions by selectively binding to and inhibiting the nuclear export protein XPO1.
XPOVIO is approved in the U.S. for multiple myeloma (搜索) and diffuse large B-cell lymphoma (搜索) (DLBCL). It is approved in combination with bortezomib and dexamethasone for multiple myeloma patients after at least one prior therapy, and with dexamethasone for heavily pre-treated multiple myeloma. It also holds accelerated approval for relapsed or refractory DLBCL after at least two lines of systemic therapy. The drug has also received regulatory approvals in various indications in other countries, marketed by Karyopharm's partners.
Selinexor is also under investigation in other clinical trials for various cancer indications, including myelofibrosis (搜索).