VERITAC-2 Trial Results - Vepdegestrant demonstrated a 5-month median PFS in patients with tumors harboring ESR1 mutations, a 2.9-month improvement over fulvestrant[17] - In the ESR1 mutant population, the 6-month PFS was 45.2% with vepdegestrant compared to 22.7% with fulvestrant[33] - Vepdegestrant showed statistically significant improvements in CBR and ORR in the ESR1 mutant population[37] - In patients with ESR1m, CBR was 42.1% for Vepdegestrant vs 20.2% for Fulvestrant, ORR was 18.6% for Vepdegestrant vs 4.0% for Fulvestrant[40] - In the ITT population, median PFS by BICR was 3.7 months for Vepdegestrant and 3.6 months for Fulvestrant[35] Safety and Tolerability - The rate of treatment discontinuation due to TEAEs was 3% in the vepdegestrant group and 1% in the fulvestrant group[45] - Any grade TRAEs occurred in 57% of patients treated with vepdegestrant and 40% of patients treated with fulvestrant[45] Market and Regulatory - Approximately 20,000 patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer are treated each year in the U S in the 2L setting[17, 51, 52] - Arvinas and Pfizer plan to submit a New Drug Application to the U S Food and Drug Administration in the coming weeks[60]