For patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, the oral proteolysis-targeting chimera ER degrader, vepdegestrant, leads to significantly longer progression-free survival in patients with ESR1 mutations, according to a study published online May 31 in the New England Journal of Medicine. The research was presented to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago.
Mario Campone, M.D., Ph.D., from the Institut de Cancérologie de l’Ouest Angers-Nantes in Saint-Herblain, France, and colleagues conducted a phase 3, open-label, randomized trial involving patients with ER-positive, HER2-negative advanced breast cancer who had received one previous line of cyclin-dependent kinase 4 and 6 inhibitor therapy plus one line of endocrine therapy. Patients were randomly assigned to receive vepdegestrant at a dose of 200 mg orally once every day of each 28-day cycle or fulvestrant at a dose of 500 mg on day 1 and day 15 of cycle 1 and on day 1 of subsequent cycles (313 and 311 patients, respectively).
The researchers found that median progression-free survival was 5.0 and 2.1 months with vepdegestrant and fulvestrant, respectively, among the 270 patients with ESR1 mutations (hazard ratio, 0.58). Median progression-free survival was 3.8 and 3.6 months with vepdegestrant and fulvestrant, respectively, among all patients. In 23.4% and 17.6% of the patients in the vepdegestrant and fulvestrant groups, respectively, adverse events of grade 3 or higher occurred; adverse events leading to discontinuation occurred in 2.9% and 0.7%, respectively.
“Additional follow-up is needed to further characterize the long-term efficacy and safety of vepdegestrant in this population,” the authors write.
The study was funded by Pfizer, which is developing vepdegestrant.
More information:
Mario Campone et al, Vepdegestrant, a PROTAC Estrogen Receptor Degrader, in Advanced Breast Cancer, New England Journal of Medicine (2025). DOI: 10.1056/NEJMoa2505725
More Information
Copyright © 2025 HealthDay. All rights reserved.
Citation:
ASCO: Vepdegestrant ups survival in ER+, HER2− advanced breast cancer with ESR1 mutations (2025, June 2)
retrieved 2 June 2025
from https://medicalxpress.com/news/2025-06-asco-vepdegestrant-ups-survival-er.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no
part may be reproduced without the written permission. The content is provided for information purposes only.
