MorphoSys Presents New Longer-term Phase 2 Results on Pelabresib in Myelofibrosis, Including Potential Disease-Modifying Activity, at ASH 2022
Current TAP Partner
Planegg/Munich, Germany, December 11, 2022 - MorphoSys AG (FSE: MOR; NASDAQ: MOR) today announced results from analyses of the ongoing MANIFEST study, an open-label Phase 2 clinical trial of pelabresib, an investigational BET inhibitor, in patients with myelofibrosis, a type of bone marrow cancer with limited treatment options. The latest analyses include longer-term data showing durable improvements in both spleen volume and symptom score beyond 24 weeks (data cutoff July 29, 2022), with pelabresib plus ruxolitinib in JAK inhibitor-naïve patients. Also presented were translational data from MANIFEST indicating the association of biomarkers with potential disease-modifying activity of pelabresib. The findings were presented during two oral sessions at the 64th American Society of Hematology (ASH 2022) Annual Meeting and Exposition in New Orleans, Louisiana.
At 24 weeks, 48 and 60, 68% (57/84), 61% (51/84) and 54% (45/84), respectively, of JAK inhibitor-naïve patients treated with pelabresib in combination with ruxolitinib achieved at least a 35% reduction in spleen volume (SVR35) from baseline. SVR35 was achieved by 80% of patients at any time on study.
Also at 24 weeks, 56% (46/82) of patients had at least a 50% reduction in their total symptom score (TSS50) from baseline, suggesting a reduction in symptom burden. At 48 and 60 weeks, 44% (36/82) and 43% (35/82) of patients, respectively, achieved TSS50.
All patients who had clinical responses (SVR35, TSS50 and hemoglobin improvement) plus reduced variant allele frequency and improvement in bone marrow fibrosis were naïve to JAK inhibitors.