Arvinas, Inc. and Pfizer Inc. announced positive topline results from the Phase 3 VERITAC-2 clinical trial evaluating vepdegestrant monotherapy against fulvestrant. The trial focused on adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer whose disease had progressed after prior treatment.
The trial met its primary endpoint in the estrogen receptor 1-mutant (ESR1m) population, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to fulvestrant. The results exceeded the pre-specified target hazard ratio of 0.60 in the ESR1m population.
Vepdegestrant was generally well tolerated, with a safety profile consistent with previous studies. While the trial did not achieve statistical significance in PFS for the overall intent-to-treat population, the positive outcome in the ESR1m subgroup represents a significant achievement as vepdegestrant is the first PROTAC degrader to demonstrate clinical benefit in a Phase 3 trial.
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