Shots:
- PharmaEssentia has reported topline data from a P-III (SURPASS-ET) study assessing P1101 (n=91) vs anagrelide (n=83) in patients (N=174) as a 2L treatment of ET for 12mos. with the US FDA filing for label extension to ET is expected by YE’25
- The study achieved its 1EP of durable hematologic response at 9 & 12mos. in the ITT population (42.9% vs 6%) plus 2EP of reduced JAK2 V617F allelic burden from 33.7% to 25.3% vs 39.7% to 37.3% (-8.4% vs -2.4% change) at 12 mos. & favorable safety with lower TRSAEs rate (2.2% vs 10%)
- P1101 is also being assessed in a P-IIb (EXCEED-ET) study in North America to evaluate its efficacy, safety & tolerability in adults with ET. Data anticipated in H2’25
Ref: BusinessWire | Image: PharmaEssentia
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