Study
Phase III, randomised, prospective, multicenter double-blind, placebo-controlled study (ENGOT-EN5/GOG-3055/SIENDO) |
Patients 18 years or older with histologically confirmed EC, who completed a single line of at least 12 weeks of taxane-platinum combination chemotherapy and achieved partial or complete response. |
Selinexor (n=174) vs. PBO (n=89 |
Efficacy
ITT |
mPFS: 5.7 vs 3.8 mos, HR: 0.76, p=0.126 |
TP53wt |
mPFS: 13.7 vs 3.7 mos , HR:0.41, p=0.002 |
Safety
Grade3 Aes: Nausea (9.4% vs 0), neutropenia (8.8% vs 0), thrombocytopenia (7.0% vs 0) |
J Clin Oncol SEP, 2023
http://doi.org/10.1200/JCO.22.02906
Reviewed by Elvin Chalabiyev, MD on Sep 23, 2023