Business UpdateJul 31, 2026, 08:39 AM
Karyopharm XPORT-EC-042 Trial Fails Primary Endpoint; Explores Strategic Options
AI Summary
Karyopharm Therapeutics announced that its Phase 3 XPORT-EC-042 trial for selinexor in endometrial cancer did not meet its primary endpoint of progression-free survival, though a trend favoring selinexor was observed in a modified intent-to-treat population. Concurrently, the company plans to submit an sNDA to the FDA in August 2026 for accelerated approval of selinexor in myelofibrosis, despite recent FDA correspondence requesting further data discussion. Amidst these developments, Karyopharm is exploring potential financing transactions and strategic alternatives to extend its cash runway and maximize stakeholder value.
Key Highlights
- XPORT-EC-042 trial for selinexor in endometrial cancer did not meet primary PFS endpoint.
- Modified ITT population (n=236) showed median PFS of 12.75 months (selinexor) vs 7.43 months (placebo).
- Hazard ratio for mITT population was 0.76 (95% CI: 0.51, 1.12) with one-sided p-value=0.0791.
- Company plans sNDA submission to FDA in August 2026 for selinexor in myelofibrosis.
- FDA requires further discussion on data to support sNDA and convert potential accelerated approval.
- Company exploring financing and strategic alternatives to extend cash runway.
Price Impact
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