On May 26, 2021 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that enrollment for its Phase 3 maintenance study evaluating selinexor in patients with endometrial cancer after combination chemotherapy is now recruiting eligible patients at participating hospitals in Belgium, Czech Republic, Germany, Italy, and Spain with Greece starting in the coming weeks (Press release, Karyopharm, MAY 26, 2021, View Source [SID1234580600]). Full study details can be found at Karyopharm.com/clinicaltrials.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The KCP-330-024/ENGOT-EN5/SIENDO study is an ongoing multicenter, blinded, placebo-controlled, randomized Phase 3 study evaluating the efficacy and safety for front-line maintenance therapy with selinexor in patients with advanced or recurrent endometrial cancer. Participants with primary stage IV or recurrent disease who had a partial or complete response after a single line of at least 12 weeks of standard taxane-platinum combination chemotherapy are randomized in a 2:1 manner to receive either maintenance therapy of 80mg of selinexor taken once per week or placebo, until disease progression. The study is expected to enroll approximately 248 participants at study sites across the United States, Canada, Israel and Europe. The primary endpoint in the study is progression free survival with the goal of the study demonstrating a hazard ratio of 0.6.
"While selinexor has been most extensively studied in patients with hematologic malignancies, there is increasing evidence that selinexor may also play an important role in the treatment of a variety of solid tumors, including patients with endometrial cancer," said Sharon Shacham, PhD, MBA, Chief Scientific Officer of Karyopharm. "As there are currently no approved drugs in the U.S. or Europe to treat patients with endometrial cancer in the maintenance setting following chemotherapy, the SIENDO study has the potential to help meaningfully advance the treatment paradigm for patients in need of new options for advanced or recurrent endometrial cancer."
About Endometrial Cancer
Endometrial cancer, more commonly known as uterine cancer, is the most common cancer of the female reproductive system, with more than 130,000 new cases and 30,000 deaths in Europe in 2020.1 Endometrial cancer is typically treated by one or a combination of treatments, including surgery, radiation therapy, and systemic treatments using medications. Combinations of these cancer treatments are often recommended, but they depend on the stage and characteristics of the cancer.