Pelabresib reduces spleen volume, symptoms related to myelofibrosis
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The combination of pelabresib plus ruxolitinib significantly increased the proportion of patients with myelofibrosis who achieved a clinically meaningful reduction in spleen volume, according to the agent’s manufacturer.
Topline data results from the double-blind phase 3 MANIFEST-2 study showed no new safety issues associated with the use of pelabresib (CPI-0610, MorphoSys) — an investigational small-molecule BET inhibitor — when combined with the JAK inhibitor ruxolitinib (Jakafi, Incyte).
“We are very pleased with this positive outcome. Pelabresib in combination with ruxolitinib demonstrated strong reductions in spleen volume and symptoms over ruxolitinib monotherapy — the most impressive benefits seen in clinical studies of patients with myelofibrosis,” Jean-Paul Kress, MD, CEO of MorphoSys, said in a press release. “Importantly, we saw significant symptom improvements for the vast majority of patients in the study. We look forward to our continued conversations with regulatory agencies and intend to file for approval in the U.S. and Europe.”
The double-blind MANIFEST-2 study enrolled 430 adults with JAK inhibitor-naive myelofibrosis. Researchers randomly assigned patients to receive either pelabresib plus ruxolitinib or placebo plus ruxolitinib.
The proportion of patients achieving at least a 35% reduction in spleen volume served as the primary endpoint, with symptom improvement as a key secondary endpoint.
Results showed a greater percentage of patients who received pelabresib achieved at least a 35% reduction in spleen volume at week 24 compared with placebo (66% vs. 35%; 95% CI, 21.6–39.3).
Additionally, researchers observed a reduction in total symptom score of 15.99 points at week 24 among patients receiving pelabresib compared with a decrease of 14.05 points in the placebo arm.
Detailed results from the MANIFEST-2 study will be presented at an upcoming medical conference, according to the release.
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