ESR1 Mutation
-
VERITAC-2: Vepdegestrant Demonstrates Clinical Benefit in ESR1-Mutated, ER+/HER2- Advanced Breast Cancer After Endocrine Therapy
Arvinas’ VERITAC-2 trial data, presented at ESMO 2025, showed vepdegestrant significantly delayed deterioration in quality of life, pain, and functionality compared to fulvestrant in ESR1-mutated ER+/HER2- advanced breast cancer patients. The trial enrolled 624 patients, with 270 harboring ESR1 mutations. Progression-free survival improved statistically, and the market awaits overall survival data, the key secondary endpoint. Vepdegestrant is a PROTAC ER degrader being co-developed with Pfizer and has received FDA Fast Track designation.
-
Giredestrant Improves Progression-Free Survival in ER-Positive Advanced Breast Cancer: Roche’s Phase III evERA Trial
Roche’s Phase III evERA trial showed promising results for giredestrant plus everolimus in ER-positive, HER2-negative advanced breast cancer after CDK4/6 inhibitor therapy. The combination significantly improved progression-free survival (PFS) compared to standard endocrine therapy plus everolimus. The PFS risk reduction was 44% in ITT and 62% in ESR1-mutated patients. While overall survival data is still maturing, a positive trend was observed. Giredestrant + everolimus could become a new standard of care.
