Pfizer, Arvinas Partnered Breast Cancer Drug Cuts Progression Risk By 43% In Trial, Seeks FDA Approval

Arvinas, Inc. ARVN on Friday announced in a press release the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) with its partner Pfizer Inc. PFE.

The application covers vepdegestrant for patients with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy.

This submission is based on Phase 3 VERITAC-2 trial results evaluating vepdegestrant versus fulvestrant.

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At the American Society of Clinical Oncology, the companies shared detailed results from the Phase 3 VERITAC-2 trial.

These detailed results follow the March 2025 announcement of the topline results from VERITAC-2.

In the trial, vepdegestrant demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) among patients with an estrogen receptor 1 (ESR1) mutation, reducing the risk of disease progression or death by 43% compared to fulvestrant.

The median PFS was 5 months with vepdegestrant versus 2.1 months with fulvestrant.

The trial did not reach statistical significance in improvement in PFS in the intent-to-treat (ITT) population, with a median PFS of 3.7 months for vepdegestrant versus 3.6 for fulvestrant.

Vepdegestrant was generally well tolerated in the trial, with a safety profile consistent with that observed in previous studies, and mostly low-grade treatment-emergent adverse events (TEAEs).

Overall survival (OS), the key secondary endpoint in VERITAC-2, was immature at the time of the analysis, with less than a quarter of the required number of events having occurred.

Additional secondary endpoints include clinical benefit rate (CBR), objective response rate (ORR), and duration of response.

In patients with an ESR1 mutation, CBR was 42.1% with vepdegestrant versus 20.2% with fulvestrant, and ORR was 18.6% with vepdegestrant versus 4.0% with fulvestrant.

The median duration of response was not reached.

ARVN, PFE Price Action: ARVN stock is up 4.91% at $7.26, and Pfizer stock is up 1.79% at $23.25 at publication on Friday.

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