Erika Hamilton, Chair, Executive Committee, Breast and Breast Program Lead at Sarah Cannon Research Institute, shared a post on LinkedIn:
“Today FDA approved vepdegestrant for the treatment of patients with ESR1m HR+ BCSM following prior endocrine therapy. Vepdegestrant is a proteolysis targeting chimera (PROTAC) and the first drug of its class to be FDA approved. It works in a novel way to degrade the estrogen receptor by harnessing the E3 ubiquitin ligase.
This approval is based on the results from VERITAC2 presented last ASCO25 which showed a more than doubling of progression-free survival (PFS) versus fulvestrant (median PFS 5.0 vs 2.1 months) in the subset of patients with ESR1-mutated, ER-positive/HER2-negative advanced breast cancer who had already received a CDK4/6 inhibitor plus endocrine therapy.
The objective response rate (ORR) among patients with ESR1m was 18.6% with vepdegestrant versus 4.0% with fulvestrant.
Any grade nausea was only 13%, any grade arthralgia ☠️ 11%, and diarrhea did not show up on the AE table (restricted to AEs occurring at at least 10%). Only 3% of patients discontinued treatment with vepdegestrant, and 2% of patients dose reduced.
Excited to have another option for our patients with ER+ ESR1m MBC!”
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