Selinexor in Advanced Liposarcoma

Summary

This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 342 total patients will be randomized to study treatment (selinexor or placebo).

Timeline

Start

2016-01-04

Primary completion

2020-10-28

Completion

2021-10-26

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry Phase 3 Double-blinded: Selinexor vs Phase 3 Double-blinded: Placebo; p = 0.0114; Hazard Ratio (HR) 0.7026 (95% CI 0.5191 to 0.9509); Log Rank reads as mixed primary results NCT02606461 ↗

registry Phase 2 Double-blinded: Selinexor vs Phase 2 Double-blinded: Placebo; p = 0.6051; Hazard Ratio, log 1.1521 (95% CI 0.5357 to 2.4778); Log Rank reads as mixed primary results NCT02606461 ↗

release “For the SEAL study's primary endpoint of progression-free survival (PFS), oral selinexor showed superiority over placebo, achieving a hazard ratio (HR) of 0.60” reads as met primary endpoint karyopharm.com ↗

release “For the SEAL study's primary endpoint of PFS, oral selinexor showed superiority over placebo, achieving a hazard ratio (HR) of 0.60” reads as met primary endpoint karyopharm.com ↗

release “SEAL study evaluating single agent, oral XPOVIO® (selinexor) versus matching placebo in patients with advanced unresectable dedifferentiated liposarcoma. The SEAL study met its primary endpoint” reads as met primary endpoint karyopharm.com ↗

release “the SEAL study met its primary endpoint” reads as met primary endpoint karyopharm.com ↗

release “The SEAL study met its primary endpoint of a statistically significant increase in median PFS.” reads as met primary endpoint karyopharm.com ↗

release “The randomized Phase 3 SEAL study of selinexor versus placebo in patients with heavily pretreated DDLS showed a significant improvement in PFS for selinexor.” reads as met primary endpoint karyopharm.com ↗

Publications

• Gounder MM, Razak AA, Somaiah N, Chawla S, Martin-Broto J, Grignani G, Schuetze SM, Vincenzi B, Wagner AJ, Chmielowski B, Jones RL, Riedel RF, Stacchiotti S, Loggers ET, Ganjoo KN, Le Cesne A, Italiano A, Garcia Del Muro X, Burgess M, Piperno-Neumann S, Ryan C, Mulcahy MF, Forscher C, Penel N, Okuno S, Elias A, Hartner L, Philip T, Alcindor T, Kasper B, Reichardt P, Lapeire L, Blay JY, Chevreau C, Valverde Morales CM, Schwartz GK, Chen JL, Deshpande H, Davis EJ, Nicholas G, Groschel S, Hatcher H, Duffaud F, Herraez AC, Beveridge RD, Badalamenti G, Eriksson M, Meyer C, von Mehren M, Van Tine BA, Gotze K, Mazzeo F, Yakobson A, Zick A, Lee A, Gonzalez AE, Napolitano A, Dickson MA, Michel D, Meng C, Li L, Liu J, Ben-Shahar O, Van Domelen DR, Walker CJ, Chang H, Landesman Y, Shah JJ, Shacham S, Kauffman MG, Attia S. Selinexor in Advanced, Metastatic Dedifferentiated Liposarcoma: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial. J Clin Oncol. 2022 Aug 1;40(22):2479-2490. doi: 10.1200/JCO.21.01829. Epub 2022 Apr 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Selinexor	Other / unclassified	60 mg	—

Indications