Pelabresib Phase 3 Trial Shows Significant Spleen Volume Reduction in Myelofibrosis

MorphoSys announced positive topline results from the Phase 3 MANIFEST-2 study evaluating pelabresib in combination with ruxolitinib compared to placebo plus ruxolitinib in JAK inhibitor-naïve adult patients with myelofibrosis.

The trial met its primary endpoint, as the combination therapy demonstrated a statistically significant and clinically meaningful improvement in the proportion of patients achieving at least a 35% reduction of spleen volume at week 24.

The key secondary endpoints assessing symptom improvement showed a strong positive trend favoring the pelabresib and ruxolitinib combination. Specifically, many patients experienced a significant decrease in their overall symptoms, like fatigue and discomfort.

“Myelofibrosis patients experience a severely diminished quality of life due to symptoms such as severe fatigue, night sweats, bone pain and fever – symptoms that can leave them bedridden for days and with limited ability to participate in daily activities. Reducing symptom burden is a primary goal of myelofibrosis treatment,” said Ruben A. Mesa, M.D., FACP, President and Executive Director, Atrium Health Levine Cancer Center and Atrium Health Wake Forest Baptist Comprehensive Cancer Center.

The results are encouraging and suggest that this treatment could help manage symptoms in people with myelofibrosis. Find out more details on the press release MorphoSys issued: https://www.morphosys.com/en/news/ad-hoc-morphosys-phase-3-study-pelabresib-myelofibrosis-demonstrates-statistically-significant