Company: ARVN
Filing Date: 2025-06-02
Form Type: 8-K
Source: 0001655759-25-000095
Chunk: 2

Company: ARVINAS, INC.
Filing Date: 2025-06-02
Form: 8-K
Item: Item 8.01
Chunk 2
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2 clinical trial included the following:

• PFS

◦ Vepdegestrant demonstrated a statistically significant and clinically meaningful improvement in PFS among ESR1m patients, reducing the risk of disease progression or death by 43% compared to fulvestrant [Hazard Ratio (“ HR”)=0.57 (95% CI 0.42 - 0.77); 2-sided P<0.001].

◦ The median PFS, as assessed by BICR, was 5.0 months with vepdegestrant versus 2.1 months with fulvestrant.

◦ Investigator-assessed PFS was consistent with the BICR-assessed PFS;

◦ In ESR1m patients, vepdegestrant demonstrated a consistent PFS benefit over fulvestrant across all pre-specified subgroups.

◦ The trial did not reach statistical significance in improvement in PFS in the ITT population, with a median PFS of 3.7 months for vepdegestrant versus 3.6 for fulvestrant [HR=0.83 (95% CI 0.68 - 1.02); 2-sided P=0.07].

• Tolerability and Safety Profile

◦ Vepdegestrant was generally well tolerated in the clinical trial, with a safety profile consistent with what has been observed in previous studies, and mostly low-grade treatment-emergent adverse events (“ TEAEs”) were reported.

◦ Rates and severity of gastrointestinal adverse events were low with vepdegestrant (nausea, 13.5%; vomiting, 6.4%; diarrhea, 6.4%). Grade 4 TEAEs were reported in five patients (1.6%) in the vepdegestrant arm versus nine patients (2.9%) in the fulvestrant arm.

◦ The three most common TEAEs observed with vepdegestrant were fatigue (26.6%), increased alanine transaminase (ALT) (14.4%) and increased aspartate aminotransferase (AST) (14.4%); and

◦ TEAEs leading to treatment discontinuation occurred in 2.9% of patients taking vepdegestrant versus 0.7% of patients taking fulvestrant.

• Other Data Points

◦ OS was immature at the time of the analysis, with less than a quarter of the required number