MorphoSys is dealing with an emerging safety issue related to pelabresib, the experimental treatment for myelofibrosis and centerpiece of its proposed $3 billion acquisition by Novartis, STAT has learned.
Physicians involved with MorphoSys’ completed Phase 3 study have reported multiple cases of palebresib-treated patients who rapidly progressed from myelofibrosis, a cancer affecting the bone marrow, to acute myeloid leukemia, a more aggressive and deadlier type of blood cancer, according to two people with knowledge of the cases. They spoke on the condition of anonymity because the cases have not been reported publicly.
To date, there have been six so-called “AML transformation” serious safety events reported among 212 patients in the pelabresib arm of the Phase 3 study compared to two similar events among 214 patients in the control arm. The Food and Drug Administration, informed about the imbalance in severe cancer progressions, issued a warning letter to all physicians involved in the study, and is said to be monitoring the situation.
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