Shots:
- FDA has received NDA of vepdegestrant (ARV-471) to treat pts with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy
- NDA was backed by P-III (VERITAC-2) trial assessing ARV-471 alone vs fulvestrant in mentioned pts (n=624) previously treated with CDK4/6 inhibitor + endocrine therapy
- Trial showed improved PFS (1EP) by 43% in ESR1-mutated pts (n=270), with mPFS of 5 vs 2.1mos. per BICR, consistent with investigator-assessed PFS; however, PFS did not reach statistical significance in ITT population (mPFS: 3.7 vs 3.6mos.). In 2EPs, ORR was 18.6% vs 4% & CBR was 42.1% vs 20.2%, while OS data was immature during analysis; data was presented at ASCO 2025 & published in The NEJM
Ref: Arvinas | Image: Arvinas and Pfizer | Press Release
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