A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer
Summary
A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer.
Timeline
- Start
- 2023-03-03
- Primary completion
- 2025-01-31
- Completion
- 2028-05-15
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry MEDIAN Vepdegestrant: 3.7 (3.6 to 5.3) Months MEDIAN Fulvestrant: 3.6 (2.2 to 3.8) Months analysis (superiority test); Vepdegestrant vs Fulvestrant; p = 0.0358 reads as met primary endpoint NCT05654623 ↗
registry MEDIAN Vepdegestrant: 5.0 (3.7 to 7.4) Months MEDIAN Fulvestrant: 2.1 (1.9 to 3.5) Months analysis (superiority test); Vepdegestrant vs Fulvestrant; p = 0.0001 reads as met primary endpoint NCT05654623 ↗
release “VERITAC-2 achieved its primary endpoint in the estrogen receptor 1-mutant population, demonstrating statistically significant and clinically meaningful improvement in progression-free survival” reads as mixed primary results arvinas.com ↗
release “The trial did not reach statistical significance in improvement in PFS in the intent-to-treat (ITT) population.” reads as mixed primary results arvinas.com ↗
release “Pivotal Phase 3 VERITAC-2 clinical trial results demonstrated 2.9-month improvement in median progression-free survival (PFS)” reads as mixed primary results arvinas.com ↗
release “the trial did not reach statistical significance in improvement in PFS in the intent-to-treat population” reads as mixed primary results arvinas.com ↗
release “In the VERITAC-2 Phase 3 study, vepdegestrant demonstrated statistically significant and clinically meaningful improvement in progression free survival compared to fulvestrant” reads as met primary endpoint arvinas.com ↗
release “Pivotal Phase 3 VERITAC-2 clinical trial results showed that vepdegestrant was generally well tolerated and reported mPFS of 5.0 months vs. 2.1 months for fulvestrant” reads as met primary endpoint rigel.com ↗
Publications
- Campone M, De Laurentiis M, Jhaveri K, Hu X, Ladoire S, Patsouris A, Zamagni C, Cui J, Cazzaniga M, Cil T, Jerzak KJ, Fuentes C, Yoshinami T, Rodriguez-Lescure A, Sezer A, Fontana A, Guarneri V, Molckovsky A, Mouret-Reynier MA, Demirci U, Zhang Y, Valota O, Lu DR, Martignoni M, Parameswaran J, Zhi X, Hamilton EP; VERITAC-2 Study Group. Vepdegestrant, a PROTAC Estrogen Receptor Degrader, in Advanced Breast Cancer. N Engl J Med. 2025 Aug 7;393(6):556-568. doi: 10.1056/NEJMoa2505725. Epub 2025 May 31.
- Hamilton EP, Ma C, De Laurentiis M, Iwata H, Hurvitz SA, Wander SA, Danso M, Lu DR, Perkins Smith J, Liu Y, Tran L, Anderson S, Campone M. VERITAC-2: a Phase III study of vepdegestrant, a PROTAC ER degrader, versus fulvestrant in ER+/HER2- advanced breast cancer. Future Oncol. 2024;20(32):2447-2455. doi: 10.1080/14796694.2024.2377530. Epub 2024 Jul 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fulvestrant | Small molecule | 500 mg | Intramuscular |
| Subject | vepdegestrant | Other / unclassified | 200 mg | Oral |