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

Karyopharm Therapeutics Inc. recently announced it has completed enrollment in the Phase 3 SENTRY trial, which is evaluating selinexor in combination with ruxolitinib in JAKi-naïve myelofibrosis patients.

“We are excited to announce that we have completed enrollment of our Phase 3 SENTRY trial and look forward to sharing top-line data from this pivotal trial in March 2026,” said Richard Paulson, President and Chief Executive Officer of Karyopharm. “Selinexor plus ruxolitinib has the potential to be the first combination therapy approved for the treatment of myelofibrosis, depending on the outcome of the data. By combining selinexor with the current standard of care, we believe we have the potential to redefine the way people living with myelofibrosis are treated.”

“I am grateful for the patients, their families and caregivers, the investigators and their clinical trial staff, as well as the extraordinary efforts of the Karyopharm team and our external partners for their help in successfully achieving this important milestone,” added Reshma Rangwala, MD, PhD, Chief Medical Officer and Head of Research of Karyopharm. “This trial is advancing our understanding of the treatment of myelofibrosis and the potential role that XPO1 inhibition may play in this disease. People living with myelofibrosis deserve new treatment options and everyone involved in SENTRY is making an important contribution towards our common goal of providing additional options to patients with this disease.”

“We are encouraged by the work that Karyopharm is doing in myelofibrosis and eagerly await data from the Phase 3 SENTRY trial,” also added Kapila Viges, Chief Executive Officer of MPN Research Foundation. “The myelofibrosis community is in need of new, more effective therapies that can help a greater number of patients beyond what is available with currently approved options. Efforts to develop new therapies bring hope to the myelofibrosis community and open the potential for patients to have more treatment options.  For patients, options matter.”

SENTRY (XPORT-MF-034; NCT04562389) is a Phase 3 clinical trial evaluating a once-weekly dose of 60 mg of selinexor in combination with ruxolitinib compared to placebo plus ruxolitinib in JAKi-naïve myelofibrosis patients with platelet counts >100 x 10⁹/L.  Patients are randomized 2-to-1 to the selinexor arm.  The co-primary endpoints for this trial are spleen volume response rate ≥ 35% (SVR35) at week 24 and the average change in absolute total symptom score (Abs-TSS) over 24 weeks relative to baseline.  The Phase 3 trial enrolled 353 patients.

Myelofibrosis is a rare blood cancer that affects approximately 20,000 patients in the US and 17,000 patients in the European Union. The disease causes bone marrow fibrosis (scarring in the bone marrow), which makes it difficult for the bone marrow to make healthy blood cells, splenomegaly (enlarged spleen), progressive anemia which often leads to symptoms like fatigue and weakness, and other disease associated symptoms including abdominal discomfort, pain under the left ribs, early satiety, night sweats and bone pain. The only approved class of therapies to treat myelofibrosis are JAK inhibitors, including ruxolitinib. Patients treated with the most commonly prescribed JAK inhibitor often require blood transfusions, and more than 30% will discontinue treatment due to anemia. Anemia and transfusion dependence are strongly correlated with poor prognosis and shortened survival. 

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of Karyopharm’s Selective Inhibitor of Nuclear Export (SINE) compounds for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved in the U.S. and marketed by Karyopharm in multiple oncology indications, including: (i) in combination with VELCADE (bortezomib) and dexamethasone (XVd) in adult patients with multiple myeloma after at least one prior therapy; (ii) in combination with dexamethasone in adult patients with heavily pre-treated multiple myeloma; and (iii) under accelerated approval in adult patients with diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. XPOVIO (also known as NEXPOVIO in certain countries) has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including but not limited to the European Union, the United Kingdom, Mainland China, Taiwan, Hong Kong, Australia, South Korea, Singapore, Israel, and Canada. XPOVIO/NEXPOVIO is marketed in these respective ex-U.S. territories by Karyopharm’s partners: Antengene, Menarini, Neopharm, and FORUS. Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high unmet need cancer indications, including in endometrial cancer and myelofibrosis. 

Karyopharm Therapeutics Inc. (Nasdaq: KPTI) is a commercial-stage pharmaceutical company whose dedication to pioneering novel cancer therapies is fueled by a belief in the extraordinary strength and courage of patients with cancer. Since its founding, Karyopharm has been an industry leader in oral compounds that address nuclear export dysregulation, a fundamental mechanism of oncogenesis. Karyopharm’s lead compound and first-in-class, oral exportin 1 (XPO1) inhibitor, XPOVIO (selinexor), is approved in the US and marketed by the company in three oncology indications. It has also received regulatory approvals in various indications in 50 ex-U.S. territories and countries, including Europe and the United Kingdom (as NEXPOVIO) and China. Karyopharm has a focused pipeline targeting indications in multiple high unmet need cancers, including in multiple myeloma, endometrial cancer, myelofibrosis, and diffuse large B-cell lymphoma (DLBCL). For more information, visit www.karyopharm.com.