Mascarenhas on the SENTRY Trial Design and Goals

John Mascarenhas, MD, professor, medicine, Icahn School of Medicine, Mount Sinai, director, Center of Excellence for Blood Cancers and Myeloid Disorders, member, The Tisch Cancer Institute, Mount Sinai, discusses the methods, design, and inclusion criteria of the phase 3 SENTRY trial (NCT04562389) for patients with JAK inhibitor treatment-naive myelofibrosis.

SENTRY is a global, multicenter, phase 1/3 study where investigators are assessing the efficacy and safety of selinexor (Xpovio) combined with ruxolitinib (Jakafi) in this patient population.

According to Mascarenhas, the primary end points of phase 3 of the trial include the proportion of patients with spleen volume reduction of greater than or equal to 35% at week 24 (SVR35), and the proportion of patients with a total symptom score reduction of greater than or equal to 50% at week 24 (TSS50), as measured by the myelofibrosis symptom assessment form V4.0.

Transcription:

0:09 | The study is a phase 3, randomized study that is going to include 306 patients who are JAK inhibitor-naive, and they will be randomized to 2:1 to ruxolitinib plus selinexor, the XPO1 inhibitor which is administered orally once a week at 60 mg weekly in a 28 day cycle vs placebo. And the coprimary end point of this global study is SVR35 at week 24 and TSS50 at week 24. A key secondary end point is an immune response at week 24.

0:44 | The inclusion criteria are patients with a diagnosis of myelofibrosis, either primary or secondary myelofibrosis, and are JAK inhibitor-naive. They have to have a DIPSS score of intermediate 1 with symptoms or intermediate to or high-risk disease and a platelet count of at least 100,000 or greater. In theory, they should not be candidates for for immediate stem cell transplantation. Patients can eventually go to transplant, but if they are being considered for transplant immediately, this would not be an option for those patients.

1:14 | In terms of exclusion, we do exclude patients with blasts that are greater than 10% in the blood or the bone marrow, as these patients would likely benefit from other types of therapies, or previous JAK inhibitor therapy or previous XPO1 inhibitor therapy.

Transcription created with AI and edited for clarity.