PharmaEssentia Reports Topline Data from P-III (SURPASS-ET) Trial of Ropeginterferon Alfa-2b-Njft (P1101) in Essential Thrombocythemia (ET)
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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
