Menarini Reports Positive Phase 3 SENTRY Trial Data for Myelofibrosis

In the pivotal SENTRY study, which enrolled 353 patients, the combination of 60 mg selinexor and ruxolitinib outperformed ruxolitinib monotherapy. At week 24, 49.8% of patients in the combination arm achieved a 35% or greater reduction in spleen volume (SVR35), compared to 28% in the control group. These reductions were noted as rapid and durable across various subgroups, including those receiving lower daily doses of ruxolitinib.

While the trial met its spleen volume goal, it did not reach statistical significance for the second co-primary endpoint, the absolute total symptom score (Abs-TSS). Patients on the combination saw a 9.9-point improvement, compared to a 10.9-point improvement in the monotherapy group. Despite this, researchers pointed to an early, promising signal in overall survival, with a hazard ratio of 0.43 indicating a potential reduction in the risk of death. Dr. Claire Harrison, a lead investigator, noted that the deep, sustained spleen responses observed in the trial are essential goals in managing myelofibrosis. The safety profile remained consistent with the individual drugs, with no new signals identified by the Menarini Group and Karyopharm Therapeutics.