AstraZeneca’s Truqap (capivasertib), in combination with Faslodex (fulvestrant), has been approved by the European Union (EU) for treating adult patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with PIK3CA, AKT1, or PTEN alterations. This approval follows a positive opinion from the Committee for Medicinal Products for Human Use, based on results from the CAPItello-291 Phase III trial.
The CAPItello-291 trial, published in The New England Journal of Medicine, showed that Truqap combined with Faslodex reduced the risk of disease progression or death by 50% compared to Faslodex alone in patients with tumors harboring PI3K, AKT, or PTEN alterations. The median progression-free survival (PFS) was 7.3 months with Truqap and 3.1 months with placebo. This significant finding offers new hope for patients struggling with advanced breast cancer.
Breast cancer remains the leading cause of cancer death in Europe, with over 140,000 deaths and more than 550,000 diagnoses in 2022. Hormone receptor (HR)-positive breast cancer, which expresses estrogen or progesterone receptors, constitutes 70% of breast cancer cases, with over 97% being ER-positive. Mutations in PIK3CA, AKT1, and PTEN affect approximately 50% of advanced HR-positive breast cancer patients.
Breakthrough in Breast Cancer Treatment: EU Approves Truqap for ER-Positive Patients
Dr. Mafalda Oliveira, a senior clinical investigator at Vall d’Hebron Institute of Oncology, emphasized the importance of this approval: “Patients with advanced ER-positive breast cancer often experience tumor progression or resistance to endocrine-based treatments. The approval of Truqap offers more time for disease control, benefiting approximately half of ER-positive breast cancer patients in Europe with these biomarkers.” Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, highlighted Truqap’s groundbreaking nature: “Truqap is the first and only AKT inhibitor approved in the EU for ER-positive breast cancer patients with specific biomarkers. This approval represents a significant advancement in providing innovative therapies for patients in need.”
The safety profile of Truqap plus Faslodex in the CAPItello-291 trial was consistent with previous studies. Regulatory applications for Truqap are under review in China and several other countries, with similar approvals already granted in the US, Japan, and other nations. Following this EU approval, Astex Therapeutics is set to receive a milestone payment from AstraZeneca upon the first commercial sale of Truqap in the EU, along with future royalties. This partnership underscores the financial and therapeutic significance of bringing new cancer treatments to market.
HR-positive breast cancer cells are often driven by estrogen receptors, and endocrine therapies targeting ER-driven disease are commonly used as first-line treatments in advanced settings, often paired with CDK4/6 inhibitors. However, resistance to these therapies is common, leading to limited treatment options and low survival rates, with only 35% of patients expected to live beyond five years after diagnosis. The approval of Truqap represents a crucial step in optimizing endocrine therapy and overcoming resistance.
Phase III Trial Shows Significant Improvement with Truqap for Advanced Breast Cancer
CAPItello-291 is a Phase III, double-blind, randomized trial evaluating Truqap combined with Faslodex versus placebo plus Faslodex for locally advanced or metastatic HR-positive, HER2-low, or negative breast cancer. The trial enrolled 708 adult patients whose disease recurred or progressed during or after aromatase inhibitor therapy, with or without a CDK4/6 inhibitor. The trial’s primary endpoints were PFS in the overall population and patients with PI3K/AKT pathway alterations, showing significant improvements with Truqap.
Truqap is a first-in-class, potent AKT inhibitor, administered twice daily in an intermittent dosing schedule. Approved in multiple countries, Truqap continues to be evaluated in Phase III trials for breast and prostate cancers. Faslodex, another cornerstone in breast cancer treatment, is used in combination with various drug classes, including CDK4/6, PI3K, and AKT inhibitors, to slow tumor growth by blocking and degrading the estrogen receptor.
AstraZeneca is pioneering new approaches in breast cancer treatment, with a comprehensive portfolio aimed at addressing diverse tumor environments. Innovations like Enhertu and Lynparza, alongside Truqap, showcase AstraZeneca’s commitment to transforming breast cancer care. Collaborations with other pharmaceutical companies are also expanding the potential of targeted therapies in challenging cancer settings.
Resource: AstraZeneca, June 20, 2024
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