CHICAGO -- A randomized trial testing the addition of selinexor (Xpovio) to ruxolitinib (Jakafi) for myelofibrosis only met one of its two primary endpoints, yet the combination also showed a potential survival benefit.
At 24 weeks, a significantly greater proportion of JAK inhibitor-naive patients achieved a 35% or greater reduction in spleen volume with ruxolitinib plus selinexor compared with ruxolitinib plus placebo (50% vs 28%, P<0.0001), reported John Mascarenhas, MD, of the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai in New York City.
That improvement did not correlate with a greater improvement in symptoms (the study's co-primary endpoint), with both arms demonstrating meaningful reductions, said Mascarenhas, and the combination was also associated with more high-grade toxicity.
But with a median follow-up of about 11 months, patients assigned to selinexor plus ruxolitinib had numerically longer overall survival (HR 0.43, 95% CI 0.19-1.00, nominal P=0.022).
"Selinexor and ruxolitinib represent a novel treatment strategy in JAK inhibitor-naive myelofibrosis," Mascarenhas said during a late-breaking presentation at the American Society of Clinical Oncology (ASCO) meeting.
