MorphoSys reports ‘strong’ topline results from Phase 3 MANIFEST-2 study

MorphoSys AG announced strong topline results from the Phase 3 MANIFEST-2 study investigating pelabresib, an investigational BET inhibitor, in combination with the JAK inhibitor ruxolitinib compared with placebo plus ruxolitinib in JAK inhibitor-naive patients with myelofibrosis. MANIFEST-2 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 in spleen volume at week 24. The key secondary endpoints assessing symptom improvement – proportion of patients achieving at least a 50% reduction in total symptom score and absolute change in total symptom score from baseline at week 24 – showed a strong positive trend favoring the pelabresib and ruxolitinib combination. In an analysis of patients classified as intermediate risk – constituting more than 90% of patients in MANIFEST-2 – the combination therapy demonstrated significant improvements in both key secondary endpoints. DIPSS was a pre-defined stratification factor in the MANIFEST-2 study protocol. “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,” said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. “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.”