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VERITAC-2: a Phase III study of vepdegestrant, a PROTAC ER degrader, versus fulvestrant in ER+/HER2- advanced breast cancer

Future Oncology, ISSN: 1744-8301, Vol: 20, Issue: 32, Page: 2447-2455
2024
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Article Description

Vepdegestrant (ARV-471) is an oral PROTAC ER degrader that binds an E3 ubiquitin ligase and ER to directly trigger ubiquitination of ER and its subsequent proteasomal degradation. In a first-in-human Phase I/II study, vepdegestrant monotherapy was well tolerated with clinical activity in pretreated patients with ER+/HER2- advanced breast cancer. The global, randomized Phase III VERITAC-2 study compares efficacy and safety of vepdegestrant versus fulvestrant in adults with ER+/HER2- advanced breast cancer after treatment with a CDK4/6 inhibitor plus endocrine therapy. Progression-free survival by blinded independent central review (primary end point) will be assessed in the intention-to-treat population and ESR1 mutation-positive subpopulation. Secondary end points include overall survival, tumor response, safety, pharmacokinetics, patient-reported outcomes, and circulating tumor DNA biomarkers. Clinical trial registration:NCT05654623 (ClinicalTrials.gov).

Bibliographic Details

Hamilton, Erika P; Ma, Cynthia; De Laurentiis, Michelino; Iwata, Hiroji; Hurvitz, Sara A; Wander, Seth A; Danso, Michael; Lu, Dongrui R; Perkins Smith, Julia; Liu, Yuan; Tran, Lana; Anderson, Sibyl; Campone, Mario

Informa UK Limited

Medicine; Biochemistry, Genetics and Molecular Biology

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