MorphoSys : Pelabresib Improves All Four Hallmarks Of Myelofibrosis In Phase 3 Study

(RTTNews) - MorphoSys AG (MOR) said that results from the Phase 3 MANIFEST-2 study, which investigated an investigational BET inhibitor "pelabresib" in combination with the JAK inhibitor ruxolitinib in JAK inhibitor-nave patients with myelofibrosis, demonstrated clear benefits across the four hallmarks of myelofibrosis, including a significant reduction in spleen size.

Myelofibrosis is characterized by four hallmarks: an enlarged spleen, anemia, bone marrow fibrosis and disease-associated symptoms.

In MANIFEST-2 study, all hallmarks were improved with the pelabresib and ruxolitinib combination versus placebo plus ruxolitinib, which is the standard of care in myelofibrosis. Ruxolitinib dosing was similar in both arms of the study and was determined based on its approved myelofibrosis indication.

The comprehensive results presented at the 65th American Society of Hematology (ASH) also show that the pelabresib combination improves anemia, disease-associated symptoms and bone marrow fibrosis, and that it is well-tolerated.

In the MANIFEST-2 study, pelabresib and ruxolitinib demonstrated a near doubling in the proportion of patients achieving a 35% reduction in spleen volume (SVR35) at 24 weeks, the primary endpoint, versus placebo plus ruxolitinib.

For the first key secondary endpoint assessing symptom reduction, absolute change in total symptom score at 24 weeks, there was a strong numerical improvement for patients receiving pelabresib and ruxolitinib versus placebo plus ruxolitinib. The response rate for the second key secondary endpoint, proportion of patients achieving 50% reduction in symptom score at 24 weeks, was also numerically greater for patients receiving pelabresib and ruxolitinib. Significant improvements in both key secondary endpoints were observed with the pelabresib combination for patients classified as intermediate-risk, who account for over 90% of the MANIFEST-2 population.

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