FDA Approval Insights: Capivasertib Plus Fulvestrant in Advanced HR+/HER2- Breast Cancer With PIK3CA, AKT1, or PTEN Alterations

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, sponsored by AstraZeneca, we had the pleasure of speaking with William J. Gradishar, MD, about the FDA approval of capivasertib (Truqap) plus fulvestrant (Faslodex) for patients with advanced hormone receptor (HR)–positive, HER2-negative breast cancer harboring PIK3CA, AKT1, or PTEN alterations. Dr Gradishar is chief of Hematology and Oncology in the Department of Medicine, as well as the Betsy Bramsen Professor of Breast Oncology and a professor of medicine (hematology and oncology) at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

On November 16, 2023, the FDA approved capivasertib in combination with fulvestrant for patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer with at least 1 PIK3CA, AKT1, or PTEN alteration whose disease has progressed on 1 or more endocrine-based regimens in the metastatic setting or who have experienced recurrence on or within 12 months of completing adjuvant therapy. This regulatory decision was supported by findings from the phase 3 CAPItello-291 trial (NCT04305496), in which treatment with the combination led to a median progression-free survival of 7.3 months (95% CI, 5.5-9.0) vs 3.1 months (95% CI, 2.0-3.7) with placebo plus fulvestrant (hazard ratio, 0.50; 95% CI, 0.38-0.65; P < .0001).

In our exclusive interview, Dr Gradishar discussed the significance of this approval, key efficacy and safety data from CAPItello-291, and how this combination may fit into the treatment paradigm for patients whose disease has progressed on a prior CDK4/6 inhibitor.

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