So VERITAC-2 was a global Phase III randomized trial for patients with ER-positive HER2-negative metastatic breast cancer that had already progressed on endocrine therapy and a CDK4/6 inhibitor. And it was randomized, one-to-one, straightforward, to vepdegestrant 200 milligrams orally once daily in a continuous fashion or fulvestrant 500 milligrams intramuscular on day one and 15 and then day one of every subsequent cycle...
So VERITAC-2 was a global Phase III randomized trial for patients with ER-positive HER2-negative metastatic breast cancer that had already progressed on endocrine therapy and a CDK4/6 inhibitor. And it was randomized, one-to-one, straightforward, to vepdegestrant 200 milligrams orally once daily in a continuous fashion or fulvestrant 500 milligrams intramuscular on day one and 15 and then day one of every subsequent cycle. The primary endpoint was progression-free survival by blinded independent central review among patients with ESR1 mutation. And then our statistical plan was if that was positive, we would go on to test progression-free survival in all comers, regardless of mutation. And this trial did meet its primary endpoint. PFS among those patients with ESR1 mutations were lengthened from 2.1 months with fulvestrant up to 5.0 months with vepdegestrant. In terms of progression-free survival in all comers, this was not significantly different. So the benefit was really among those patients that had an ESR1 mutation. And when we looked at some key secondary endpoints, including clinical benefit rate and objective response rate with those patients that had ESR1 mutations, clinical benefit rate was double with vepdegestrant, 20.2 versus 42.1 percent. and objective response rate was more than quadrupled, 4% up to 18.6% with vepdegestrant.
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