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Arvinas Announces New Patient-Reported Outcomes Data from Phase 3 VERITAC-2 Trial

Strategic Insights

— 2 min read

Arvinas, Inc. has announced that new data from the Phase 3 VERITAC-2 clinical trial will be presented at the European Society for Medical Oncology (ESMO) Congress, scheduled to take place from October 17 through 21, 2025, in Berlin, Germany. The data will focus on patient-reported outcomes (PROs) for vepdegestrant, a novel investigational PROTAC estrogen receptor (ER) degrader, in comparison to fulvestrant in patients with estrogen receptor 1 (ESR1) gene mutated ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer.

The presentations at ESMO will highlight the efficacy and safety of vepdegestrant as a monotherapy for patients with ER+/HER2- advanced or metastatic breast cancer, with ESR1 mutations in the second line-plus setting. The data also intends to demonstrate the potential of vepdegestrant in combination with other therapies for ER+/HER2- breast cancer.

Key Takeaways:

  • New data from the Phase 3 VERITAC-2 clinical trial assessing vepdegestrant's efficacy and safety in patients with ER+/HER2- advanced breast cancer with ESR1 mutations will be presented.
  • Vepdegestrant, a PROTAC ER degrader, is being developed as a potential monotherapy for ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations in the second line-plus setting.
  • The ongoing studies are also evaluating vepdegestrant as a monotherapy and as part of combination therapy for ER+/HER2- breast cancer.
  • Arvinas and Pfizer have a global collaboration for the co-development and co-commercialization of vepdegestrant.
  • The U.S. FDA has accepted the NDA for vepdegestrant for its use as a monotherapy in the treatment of adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy.
  • Vepdegestrant has been granted Fast Track designation by the FDA, supporting its potential as a new treatment option for patients with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy.
  • Arvinas is currently progressing multiple investigational drugs through clinical development programs, including vepdegestrant.

Statistics:

  • The VERITAC-2 trial is a Phase 3 clinical trial evaluating vepdegestrant in patients with ER+/HER2- advanced breast cancer with ESR1 mutations.
  • The trial is assessing the efficacy and safety of vepdegestrant as a monotherapy in the second line-plus setting.
  • The ongoing studies are also evaluating vepdegestrant as a monotherapy and as part of combination therapy for ER+/HER2- breast cancer.
  • Arvinas and Pfizer have a global collaboration for the co-development and co-commercialization of vepdegestrant.
  • The U.S. FDA has accepted the NDA for vepdegestrant for its use as a monotherapy in the treatment of adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy.

Sources:

  • GlobeNewswire (2025-10-13)
  • European Society for Medical Oncology (ESMO) Website

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