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Clinical trials

Vepdegestrant Demonstrates Statistically Significant Improvement in Patient-Reported Outcomes Compared to Fulvestrant in Phase 3 VERITAC-2 Clinical Trial

Strategic Insights

— 2 min read

New patient-reported outcomes data from the Phase 3 VERITAC-2 clinical trial evaluating vepdegestrant, a novel investigational PROTAC estrogen receptor degrader, demonstrated statistically significant improvements in overall quality of life, pain, and multiple functioning domains compared to fulvestrant in patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer. These findings complement previously reported clinical efficacy and safety data from the VERITAC-2 clinical trial, reinforcing vepdegestrant as a potential treatment option for patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy.

Key Takeaways:

  • Vepdegestrant demonstrated a statistically significant delay in deterioration of overall quality of life, pain, and multiple functioning domains compared to fulvestrant in patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer.
  • Patients treated with vepdegestrant reported a statistically significant delay in deterioration of overall health status, pain severity, and functioning (including role, cognitive, emotional, and social functioning) compared to fulvestrant.
  • Vepdegestrant consistently showed reduced risk of deterioration versus fulvestrant across all patient-reported outcome domains.
  • The Phase 3 VERITAC-2 clinical trial enrolled 624 patients, 270 of whom had ESR1-mutated disease, at 213 sites in 25 countries.
  • Patients were randomized 1:1 to receive either vepdegestrant once daily, orally on a 28-day continuous dosing schedule, or fulvestrant, administered intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each 28-day cycle starting from Day 1 of Cycle 2.
  • Vepdegestrant has been granted Fast Track designation by the FDA for the treatment of adults with ER+/HER2- ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy.
  • Arvinas and Pfizer are currently progressing multiple investigational drugs through clinical development programs, including vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; ARV-102, targeting LRRK2 for neurodegenerative disorders; and ARV-806, targeting KRAS G12D for mutated cancers, including pancreatic and colorectal cancers.

Statistics:

  • 43% of patients (n=270) had ESR1 mutations detected in the VERITAC-2 clinical trial.
  • The primary endpoint was progression-free survival (PFS) in the ESR1-mutation and intent-to-treat populations as determined by blinded independent central review.
  • Overall survival is the key secondary endpoint.

Sources:

  • "Arvinas Announces New Patient-Reported Outcomes Data from the Phase 3 VERITAC-2 Clinical Trial of Vepdegestrant (ARV-471) in Patients with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer." GlobeNewswire, 20 Oct. 2025, news.globeinvestorcentre.com.
  • "Veritac-2 Clinical Trial.," ClinicalTrials.gov, clinicaltrials.gov.
  • "Vepdegestrant.," Arvinas, Inc., arvinas.com.
  • "About Us.," Arvinas, Inc., arvinas.com.
  • "Contact Us.," Arvinas, Inc., arvinas.com.

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