RE:RE:Novartis US$2.9 Billion MorphoSys BET Inhibitor safety issue November 21, 2023 - MorphoSys CEO Jean-Paul Kress’ words are coming back to haunt him. The MorphoSys CEO has previously said AbbVie “failed” its phase 3 myelofibrosis trial because the Big Pharma missed one of two endpoints. Now, Kress is defending MorphoSys’ similarly mixed data on its $1.7 billion rival.
The data come from a phase 3 clinical trial of pelabresib, a BET inhibitor that MorphoSys acquired in its $1.7 billion acquisition of Constellation Pharmaceuticals. The study tested the effect of giving pelabresib and the JAK inhibitor ruxolitinib to myelofibrosis patients. After 24 weeks, MorphoSys saw a significant improvement in the proportion of patients achieving at least a 35% reduction in spleen volume (SVR35).
That significant improvement caused the study to hit its primary endpoint. The problem for MorphoSys is that, until recently, management had consistently said a hit on the spleen volume endpoint was one of two outcomes needed to unlock the myelofibrosis market.
Pelabresib failed on the second key measure. The study found 52% of patients taking pelabresib and ruxolitinib had at least a 50% reduction in total symptom score (TSS50), compared to 46% of people who took placebo with the JAK inhibitor.
https://www.fiercebiotech.com/biotech/morphosys-after-saying-abbvie-failed-defends-own-mixed-blood-cancer-data-plots-approval