Study
| Phase 3, open-label, randomized trial (VERITAC-2) |
| ER-positive, HER2-negative advanced breast cancer pts previously treated with CDK4/6 inhibitor and endocrine therapy |
| Vepdegestrant 200 mg PO daily vs. Fulvestrant 500 mg IM |
Efficacy
| mPFS: 5.0 mos vs. 2.1 mos (ESR1-mutated subgroup) (HR: 0.58 [0.43-0.78]) |
| mPFS: 3.8 mos vs. 3.6 mos (overall population) (HR: 0.83 [0.69-1.01]) |
| ORR: 18.6% vs. 4.0% (ESR1-mutated subgroup) |
Safety
| Grade ≥3 AEs: 23.4% vs. 17.6% |
| Treatment-related discontinuation: 2.9% vs. 0.7% |
| Any-grade AEs: fatigue (26.6% vs. 15.6%), elevated AST (14.4% vs. 10.4%), ALT (14.4% vs. 9.8%), nausea (13.5% vs. NR) |
| QT prolongation (any grade): 9.9% vs. 1.3% (Grade 3: 1.6% vs. 0.3%) |
N Engl J Med. Piublished May 31, 2025
http://doi.org/10.1056/NEJMoa2505725
Reviewed by Ulas D. Bayraktar, MD on Jun 2, 2025
