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Kelly McCann, MD, PhD, discusses the need to reach consensus on the potential role of vepdegestrant for ER-positive, HER2-negative advanced breast cancer.
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"Trying to figure out what we're going to do with this data [also] includes the fact that patients [may] have a preference [of receiving an oral treatment vs fulvestrant]. Our next round of trials is [focused on] combination therapies, and so maybe we will, in the future, have vepdegestrant or other oral SERDs as our alternative to fulvestrant."
Kelly McCann, MD, PhD, a medical oncologist and an assistant clinical professor of medicine at the UCLA Health David Geffen School of Medicine, addressed the clinical importance of reaching consensus on how vepdegestrant, an investigational proteolysis targeting chimera protein degrader, could be incorporated into existing treatment algorithms for estrogen receptor–positive, HER2-negative advanced breast cancer.
At the 2025 Bridging the Gaps in Breast Cancer meeting, McCann and colleagues discussed results of the phase 3 VERITAC-2 trial (NCT05654623), which evaluated vepdegestrant vs fulvestrant (Faslodex) in patients with ER-positive, HER2-negative advanced breast cancer who had prior endocrine therapy exposure. Findings from the study demonstrated a statistically significant improvement in progression-free survival for vepdegestrant in the ESR1-mutant population (stratified HR, 0.57; 95% CI, 0.42-0.77; 2-sided P < .001). However, the improvement was not statistically significant in the all-comers population (HR, 0.83; 95% CI, 0.68-1.02; P = .07).
McCann emphasized the need to clearly define the drug’s role, particularly as novel oral selective ER degraders (SERDs) emerge in the therapeutic landscape. According to McCann, the ability of vepdegestrant to demonstrate clinical activity in the ESR1-mutant population—a group known to harbor resistance to aromatase inhibitors—positions the agent as a promising alternative endocrine therapy. However, she noted that despite encouraging efficacy data, consensus is still needed regarding how best to integrate vepdegestrant into sequencing strategies, particularly in the second-line setting and beyond.
Establishing a consensus will require alignment on multiple factors, including comparative effectiveness vs fulvestrant, real-world patient adherence and preference for oral therapies, and ongoing results from combination studies with CDK4/6 or targeted therapies. McCann underscored that patient preference will likely favor oral SERDs or PROTACs over fulvestrant, but integration should be driven by both clinical outcomes and logistical considerations such as route of administration, toxicity, and cost.
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