Karyopharm Announces Topline Results from Phase 3 XPORT-EC-042 Trial in Endometrial Cancer

Rákkutatás · Endometrial cancer · TP53

Karyopharm’s Phase 3 XPORT-EC-042 trial of selinexor as maintenance therapy in TP53 wild‑type/endometrial cancer did not meet the primary endpoint of progression‑free survival, although a non‑significant trend toward longer median PFS was observed.

In a Phase 3 randomized double‑blind placebo‐controlled trial (XPORT‑EC‑042; NCT05611931) selinexor 60 mg weekly was tested as maintenance therapy after chemotherapy or chemo‑plus‑checkpoint inhibitor in adult patients with TP53 wild‑type advanced or recurrent endometrial cancer. The primary endpoint, progression‑free survival, was not met (median PFS 12.75 mo vs 7.43 mo, HR = 0.76 [95% CI 0.51‑1.12]; p = 0.0791). The safety profile was consistent with known selinexor toxicity, with no new safety signals. Despite not achieving statistical significance, the observed 5.3‑month improvement in median PFS is considered encouraging for an unmet‑needs patient group.

Selinexor’s XPO1 inhibition showed a clinically meaningful, though not statistically significant, median PFS gain of ~5 months in TP53 wild‑type endometrial cancer patients, a group that currently lacks effective maintenance options.

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