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Karyopharm Therapeutics announced that its Phase 3 XPORT-EC-042 trial of selinexor as maintenance therapy for TP53…
KPTIKaryopharm Therapeutics Inc.
Karyopharm Therapeutics announced that its Phase 3 XPORT-EC-042 trial of selinexor as maintenance therapy for TP53 wild-type endometrial cancer failed to meet the primary endpoint of progression-free survival, though a trend favoring selinexor was observed in the mITT population (median PFS 12.75 months vs 7.43 months; HR=0.76). The company plans to submit a supplemental New Drug Application for accelerated approval of selinexor with ruxolitinib for myelofibrosis in August 2026, following FDA feedback that spleen volume reduction qualifies as a surrogate endpoint, though the agency requested further discussion on data to support conversion to traditional approval. Additionally, Karyopharm is exploring potential financing transactions and strategic alternatives with Centerview Partners to extend its cash runway. The company operates in the biotechnology industry, developing and commercializing therapies for cancer and hematologic diseases.