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Selinexor

Safety and Efficacy of Selinexor in Combination With Pembrolizumab in Recurrent Advanced Melanoma

Ensayo de Karyopharm Therapeutics Inc. en Locally Advanced Unresectable or Metastatic Melanoma (del registro, en inglés).

Lo que ha anunciado la empresa

La empresa anunció que NO alcanzó su objetivo principal…Phase 3 XPORT-EC-042 trial (NCT05611931), evaluating selinexor as a maintenance-only therapy compared to placebo in adult patients with TP53 wild-type advanced or recurrent endometrial cancer. The trial did not meet its primary endpoint of progression-free survival. A trend favoring the selinexor arm was observed in the modified intent to treat (mITT) population (n=236), with a median PFS of 12.75 months in the selinexor arm compared…

En un 8-K del 13 ago 2026, en una frase que nombra «Selinexor». El documento en la SEC.

La empresa anunció que NO alcanzó su objetivo principal…results from its Phase 3 XPORT-EC-042 trial evaluating selinexor as a maintenance-only therapy compared to placebo in adult patients with TP53 wild-type advanced or recurrent endometrial cancer. The trial did not meet its primary endpoint of progression free survival (“PFS”). In the trial, patients were randomized 1:1 to receive either a 60 mg, once-weekly, administration of oral selinexor or placebo until disease progression. The trial…

En un 8-K del 31 jul 2026, en una frase que nombra «Selinexor». El documento en la SEC.

La empresa anunció que alcanzó su objetivo principal…results from the Phase 3 SENTRY trial, a randomized, double-blind trial evaluating 60 mg selinexor in combination with ruxolitinib in frontline myelofibrosis compared to ruxolitinib alone (n=353). The trial met the first co-primary endpoint of spleen volume reduction of 35% or more (SVR35) at week 24 and also demonstrated rapid, deep and sustained improvement in this endpoint over time. The trial did not meet its second co-primary endpoint…

En un 8-K del 14 may 2026, en una frase que nombra «Selinexor». El documento en la SEC.

Fase

Fase 2

Estado

Interrumpido

Participantes

15

previstos

Centros

13

Fin del objetivo primario

sep 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en may 2021.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The trial was terminated due to a lack of sufficient anti-melanoma tumor signal for the combination of selinexor + pembrolizumab.».

Qué mide

Overall Response Rate (ORR) Assessed as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (From the date of randomization until the documentation of CR or PR, whichever occurs first (up to 24 months)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroApproximately 40 participants with locally advanced or metastatic melanoma will be enrolled in 20 sites in the United States into 1 of the following 2 arms: Primary resistance to initial checkpoint inhibitor (CPI) therapy in Arm A and Acquired resistance to initial CPI therapy in Arm B. Participants who have disease progression (PD) after discontinuation of CPIs, especially in neoadjuvant or adjuvant therapy, will be considered to have acquired resistance in this study. Participants will receive study treatment (Selinexor and Pembrolizumab) until PD, intolerable toxicity or withdrawal from the study, whichever occurs first.

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Ficha completa en ClinicalTrials.gov (NCT04768881), actualizada en ago 2024.