MorphoSys shares phase 3 trial results for pelabresib in myelofibrosis treatment

Betsy Goodfellow | November 23, 2023 | News story | Research and Development Haematology, clinical trial, morphosys, myelofibrosis, pelabresib 

MorphoSys has announced topline results from its phase 3 MANIFEST-2 study, which assessed pelabresib, an investigational BET inhibitor, in combination with ruxolitinib, a JAK inhibitor for the treatment of JAK inhibitor-naïve patients with myelofibrosis.

The trial met its primary endpoint, demonstrating 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 secondary endpoints assessed symptom improvement, and showed a strong positive trend in favour of the drug combination. These secondary endpoints included the proportion of patients achieving at least a 50% reduction in total symptom score and an absolute change in total symptom score from baseline at week 24.

Jean-Paul Kress MD, chief executive officer of MorphoSys, commented: “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. 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 US and Europe.”

Betsy Goodfellow

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