MorphoSys : Phase 3 Study Of Pelabresib Combination In Myelofibrosis Meets Primary Endpoint

(RTTNews) - MorphoSys AG (MOR) announced strong 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-nave patients with myelofibrosis.

The company noted that the study 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 (SVR35) at week 24.

The key secondary endpoints assessing symptom improvement-proportion of patients achieving at least a 50% reduction in total symptom score (TSS50) and absolute change in total symptom score (TSS) 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 (Dynamic International Prognostic Scoring System [DIPSS] Int-1 and Int-2) - 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.

MorphoSys said it will continue conversations with regulatory agencies, with intention to submit a New Drug Application for pelabresib in combination with ruxolitinib in myelofibrosis to the FDA and a Marketing Authorization Application to the European Medicines Agency in the middle of 2024.

The combination therapy received Fast Track designation for this disease from the FDA in 2018.

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