Karyopharm : Data In Selinexor-Treated Patients With Endometrial Cancer Shows Improvements In PFS

(RTTNews) - Karyopharm Therapeutics Inc. (KPTI) said that primary analysis of phase 3 SIENDO study of selinexor maintenance therapy in advanced or recurrent endometrial cancer showed improvements in median progression-free survival or PFS for the intent-to-treat or ITT population but were not clinically meaningful. However, an exploratory analysis of a pre-specified subgroup of patients with TP53 wild-type endometrial cancer showed a promising efficacy signal.

The updated long-term safety and efficacy data from a pre-specified exploratory subgroup analysis of the SIENDO study (NCT03555422) in patients with advanced or recurrent TP53 wild-type endometrial cancer were presented at the International Gynecological Cancer Society (IGCS) Annual Global Meeting in Seoul, South Korea.

In the exploratory subgroup analysis, 113 patients with wild-type endometrial cancer received selinexor (n=77) or placebo (n=36) as maintenance therapy. Although the survival data are immature, as of the September 1, 2023, data cut-off date, the study showed an encouraging OS signal in the TP53 wild-type population: hazard ratio 0.76 (95% Confidence Interval), with median OS not reached in either arm after a median follow up of 28.9 months.

The company noted that no new safety signals were identified as of the last data cut-off date on September 1, 2023. The most common treatment-emergent adverse events (AEs) with selinexor treatment were nausea (90%), vomiting (60%), thrombocytopenia (42%) and diarrhea (42%), the majority of which were grades.

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