Karyopharm Announces Completion of Enrollment in the Phase 3 SENTRY Trial in Myelofibrosis

Core Insights - Karyopharm Therapeutics has completed enrollment in the Phase 3 SENTRY trial, which is evaluating the combination of selinexor and ruxolitinib in patients with myelofibrosis [1][2] - The trial aims to provide top-line data in March 2026, with the potential for selinexor plus ruxolitinib to become the first approved combination therapy for myelofibrosis [2] - Myelofibrosis is a rare blood cancer affecting approximately 20,000 patients in the U.S. and 17,000 in the EU, with current treatment options limited to JAK inhibitors [3] Company Overview - Karyopharm Therapeutics is a commercial-stage pharmaceutical company focused on developing novel cancer therapies, particularly through its lead compound, XPOVIO (selinexor), which is an oral exportin 1 (XPO1) inhibitor [5][12] - XPOVIO is approved in the U.S. for multiple oncology indications and has received regulatory approvals in various countries, including the EU and China [6][12] - The company is advancing its pipeline to address high unmet needs in cancers such as multiple myeloma, endometrial cancer, and diffuse large B-cell lymphoma [12] Clinical Trial Details - The SENTRY trial enrolled 353 patients and evaluates a once-weekly dose of 60 mg of selinexor in combination with ruxolitinib compared to placebo plus ruxolitinib [2] - Co-primary endpoints include spleen volume response rate of 35% at week 24 and average change in absolute total symptom score over 24 weeks [2] - The trial targets JAKi-naïve myelofibrosis patients with platelet counts greater than 100 x 10/L, with a randomization ratio of 2-to-1 favoring the selinexor arm [2] Industry Context - Myelofibrosis is characterized by bone marrow fibrosis, leading to anemia and other debilitating symptoms, with current treatments often resulting in transfusion dependence [3] - The myelofibrosis community is in need of new therapies, as existing JAK inhibitors have limitations, including a high discontinuation rate due to anemia [3] - The development of new combination therapies like selinexor plus ruxolitinib could significantly impact treatment paradigms for myelofibrosis patients [2][3]