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Karyopharm Completes Patient Recruitment in Phase 3 SIENDO Study of Selinexor in Patients with Endometrial Cancer
- Top-Line Study Results Expected by End of 2021 or Early 2022 - NEWTON, Mass., Dec. 2, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a
About this update from Karyopharm Therapeutics Inc.
[{"type":"text","content":"- Top-Line Study Results Expected by End of 2021 or Early 2022 -\n\n\nNEWTON, Mass., Dec. 2, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced the completion of patient recruitment in the Phase 3 SIENDO study evaluating the efficacy and safety for front-line maintenance therapy with selinexor in patients with advanced or recurrent endometrial cancer.\nEndometrial cancer is the most common cancer of the female reproductive organs, with more than 66,000 new cases in the US in 2021.1 Unfortunately, prognosis is poor with an estimated 14,000 women progressing to advanced disease.2 There are currently no approved therapies in the maintenance setting for patients with advanced or recurrent endometrial cancer.\n\"There is a clear and significant need for treatments that help extend remission or delay disease progression following front-line chemotherapy treatment in patients with endometrial cancer,\" said Sharon Shacham, PhD, Chief Scientific Officer of Karyopharm. \"Completing enrollment in the Phase 3 SIENDO study is an important step toward our goal of delivering a novel, front-line maintenance therapy for patients and positive data from this study will further reinforce our views on the therapeutic potential of selinexor in solid tumor indications. We anticipate reporting top-line data from this event-driven study by the end of this year or early next year.\"\nThe SIENDO study has exceeded its enrollment goal, with over 250 patients currently enrolled or in screening. The SIENDO study is a multicenter, blinded, placebo-controlled, randomized Phase 3 study evaluating the efficacy and safety for 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 primary endpoint in the study is progression free survival with the goal of the study demonstrating a hazard ratio of 0.6. \nAbout XPOVIO® (selinexor)\nXPOVIO is a first-in-class, oral Selective Inhibitor o...