The VERITAC-2 (NCT05654623) Phase 3 clinical trial was initiated in March of 2023 with the goal of learning more about ARV-471 (vepdegestrant), a new medicine for people who have advanced metastatic breast cancer. The trial’s primary completion date was January 31, 2025, and results from the trial were integral in the May 2026 approval of vepdegestrant (Veppanu) for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

The VERITAC-2 trial’s goal was to learn about vepdegestrant compared to fulvestrant in participants with advanced breast cancer. The trial enrolled 624 participants from the United States and 30 other countries. Inclusion criteria included adults, 18 and older, who met the trial’s ten inclusion criteria – which included confirmed diagnosis of ER+/HER2- breast cancer, among other qualifiers. The study featured two arms: Vepdegestrant, received the drug orally, daily, on a 28-day dosing schedule; Fulvestrant, received intramuscularly on days 1 and 15 of cycle 1 and then on day 1 of each cycle starting from C2D1 (28-day cycle).

The trial revealed that among patients with ESR1 mutation, vepdegestrant demonstrated a significant improvement in PFS, reducing the risk of disease progression by 43% compared to fulvestrant. The majority of adverse events observed with vepdegestrant were low grade. VERITAC-2’s estimated study completion is set for May 2028. 

A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer (VERITAC-2)

  • Sponsor: Pfizer
  • Description: A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer.
  • Interventions: ARV-471 (vepdegestrant), fulvestrant
  • Primary Outcome Measures: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1- All Randomized Participants; PFS by BICR Assessment Per RECIST v1.1-Participants With ESR1 Mutation.
  • Time Frames: From date of randomization to date of first documentation of objective PD or death (any cause) or censoring date, whichever occurred first (up to 18.56 months and 19.38 months of treatment exposure for vepdegestrant and fulvestrant arms respectively); From date of randomization to date of first documentation of objective PD or death (any cause) or censoring date, whichever occurred first (up to 18.56 months and 19.38 months of treatment exposure for vepdegestrant and fulvestrant arms respectively).
  • Anticipated Completion: May 2028
  • Study Details
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