Karyopharm Therapeutics has reached a significant milestone by completing patient enrolment for its Phase III SENTRY trial.
This study is investigating the potential of selinexor, in combination with ruxolitinib, for patients with myelofibrosis who have not previously received JAK inhibitor treatment.
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Known formally as XPORT-MF-034 (NCT04562389), the trial compares a weekly dose of 60mg selinexor plus ruxolitinib to a placebo with ruxolitinib. Participants are divided into groups with a 2:1 ratio favouring the selinexor treatment.
The primary objectives are to measure a spleen volume response rate of at least 35% at week 24 and to track changes in the absolute total symptom score over the same period. The trial includes 353 participants.
The company anticipates sharing top-line data from the SENTRY trial in March 2026.
Myelofibrosis is a rare blood cancer affecting approximately 20,000 people in the US and 17,000 people in the European Union. It causes bone marrow scarring, leading to issues such as splenomegaly, anaemia, and fatigue.
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By GlobalDataJAK inhibitors, such as ruxolitinib, are currently the only approved treatments for myelofibrosis. These treatments often require blood transfusions, and over 30% of patients stop treatment due to anaemia. The condition is associated with a poor prognosis and reduced survival rates.
Xpovio is an oral exportin 1 (XPO1) inhibitor and represents Karyopharm’s first Selective Inhibitor of Nuclear Export (SINE) compound for cancer treatment. It functions by inhibiting the nuclear export protein XPO1.
In the US, Xpovio is approved for various oncology indications, including multiple myeloma and diffuse large B-cell lymphoma. Outside the US, known as Nexpovio, it has received approval in regions such as the European Union, the UK, and several Asian territories.
Karyopharm’s partners, including Antengene and Menarini, market the drug in these regions. Selinexor is also being tested in additional trials for unmet cancer needs, including endometrial cancer and myelofibrosis.
Karyopharm Therapeutics CEO and president Richard Paulson said: “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.”
In 2023, Karyopharm released interim data from the Phase II segment of its open-label Phase I/II trial of eltanexor (KPT-8602) as a single-agent treatment for higher-risk relapsed/refractory myelodysplastic neoplasms.
