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Arvinas and Pfizer's Vepdegestrant Significantly Improves Progression-Free Survival for ...

  • Arvinas and Pfizer presented positive Phase 3 VERITAC-2 trial results on May 31, 2025, in Chicago for vepdegestrant versus fulvestrant in ER+/HER2- advanced breast cancer patients with ESR1 mutations.
  • The trial tested vepdegestrant, an oral PROTAC ER degrader, in 624 patients previously treated with CDK4/6 inhibitors and endocrine therapy, focusing on those with ESR1 mutations that confer treatment resistance.
  • Vepdegestrant improved median progression-free survival to 5.0 months from 2.1 months with fulvestrant among 270 ESR1-mutant patients, showing a hazard ratio of 0.57 and a P value under 0.001.
  • While generally well tolerated with fewer gastrointestinal events, grade 3 adverse events occurred in 23.4% of vepdegestrant patients versus 17.6% with fulvestrant, and discontinuations were low at 2.9%.
  • These results support a planned FDA New Drug Application submission in late 2025, though further follow-up is needed and regulatory and clinical risks remain for the drug's future use and commercial success.
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biopharmadive.com broke the news in on Saturday, May 31, 2025.
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