Arvinas/Pfizer vepdegestrant VERITAC-2: PFS benefit in ESR1m patients; NDA in H2 2025

ARVINAS, INC.

In ESR1m patients, vepdegestrant reduced progression/death risk by 43% (HR=0.57); median PFS 5.0 vs 2.1 months (p<0.001).
ITT population median PFS 3.7 vs 3.6 months (HR=0.83, p=0.07), not statistically significant.
Secondary endpoints in ESR1m: ORR 18.6% vs 4.0% (OR 5.45), CBR 42.1% vs 20.2% (OR 2.88).
Safety profile generally well tolerated; GI events low (nausea 13.5%); discontinuation 2.9% vs 0.7%.
Companies plan to submit NDA to FDA in H2 2025; OS data immature at analysis.

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