Karyopharm Completes Enrollment in Myelofibrosis Phase 3 SENTRY Trial: A New Dawn for Treatment

Karyopharm's SENTRY Trial for Myelofibrosis Reaches Enrollment Milestone

Karyopharm Therapeutics Inc., a prominent player in the pharmaceutical sector known for its innovation in cancer therapies, has officially announced the completion of patient enrollment for its pivotal Phase 3 SENTRY trial. This trial, which is centered on the treatment of myelofibrosis, evaluates the efficacy of selinexor combined with ruxolitinib in patients who are yet to receive JAK inhibitors. The completion of this milestone is a significant step forward for Karyopharm and the many patients affected by this rare condition.

Richard Paulson, the President and CEO of Karyopharm, expressed his enthusiasm: "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." He highlighted the potential of this combination therapy to be the first treatment of its kind approved for myelofibrosis, emphasizing the hope this brings to patients and their families.

Importance of the SENTRY Trial

The SENTRY trial (known as XPORT-MF-034; NCT04562389) represents a critical investigation into the treatment of myelofibrosis. This blood cancer affects an estimated 20,000 individuals in the U.S. and 17,000 in Europe, characterized by bone marrow scarring that inhibits the production of healthy blood cells. The disease often leads to serious complications like splenomegaly, anemia, and debilitating symptoms that reduce the quality of life.

Within the framework of this trial, 353 patients will receive either a weekly dose of 60 mg of selinexor combined with ruxolitinib or a placebo with ruxolitinib. The co-primary endpoints are aimed at measuring the spleen volume response rate and the overall symptom burden experienced by the patients over a 24-week period.

Collaborative Efforts and Community Hope

Dr. Reshma Rangwala, Karyopharm's Chief Medical Officer, acknowledged the team effort involved in reaching this crucial milestone. She stated, "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."

Industry advocate Kapila Viges, CEO of the MPN Research Foundation, acknowledged the high demand for innovative treatments in the myelofibrosis landscape. "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."

Understanding Myelofibrosis

Myelofibrosis, categorized as a rare blood cancer, comes with a troubling prognosis. It often complicates the lives of those affected through various symptoms including fatigue, early satiety, and bone pain. Existing FDA-approved therapies primarily consist of JAK inhibitors, like ruxolitinib, which, while beneficial, present challenges including reliance on blood transfusions for many patients. Notably, more than 30% of patients treated with these therapies may discontinue treatment due to anemia and its associated difficulties.

As of now, Karyopharm’s selinexor (marketed as XPOVIO®) is already an established treatment for several oncology conditions. Its safety profile is being further evaluated in conjunction with current standards of care, aiming to revolutionize treatment approaches for myelofibrosis.

Looking Ahead

As the SENTRY trial unfolds, expectations are set high for the potential approval of a new combination therapy that could change the standard of care for myelofibrosis. With top-line results anticipated in March 2026, all eyes are on Karyopharm’s contribution to this pressing healthcare need. The outcomes of this clinical trial will be closely monitored, marking a potential breakthrough in providing hope and new options for those affected by myelofibrosis. The determination of Karyopharm, alongside the collaborative efforts of the medical community, reflects a shared commitment to enhancing life quality for patients battling this challenging disease.