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Truqap Plus Faslodex Approved in EU for Advanced ER-Positive Breast Cancer

First AKT Inhibitor Approved in EU for Breast Cancer with Specific Biomarker Alterations (PIK3CA, AKT1, or PTEN)

AstraZeneca's Truqap (capivasertib) combined with Faslodex (fulvestrant) has received approval in the European Union (EU) for treating adult patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer, marked by one or more PIK3CA, AKT1, or PTEN mutations, following recurrence or progression after endocrine therapy.

This approval by the European Commission is grounded in the positive recommendation from the Committee for Medicinal Products for Human Use and supported by results from the CAPItello-291 Phase III trial, published in The New England Journal of Medicine.

In the CAPItello-291 trial, the combination of Truqap and Faslodex demonstrated a 50% reduction in the risk of disease progression or death compared to Faslodex with placebo in patients with tumors exhibiting PI3K, AKT, or PTEN alterations (median progression-free survival of 7.3 months versus 3.1 months).

Breast cancer remains the leading cause of cancer mortality in Europe, with over 140,000 deaths and more than 550,000 diagnoses in 2022. Hormone receptor (HR)-positive breast cancer, characterized by the presence of estrogen or progesterone receptors, is the most prevalent subtype, comprising 70% of breast cancers and more than 97% of HR-positive tumors being ER-positive. Mutations in PIK3CA, AKT1, and PTEN alterations are common, impacting around 50% of patients with advanced HR-positive breast cancer.

CAPItello-291 Trial Overview

The CAPItello-291 trial is a Phase III, double-blind, randomized study assessing the efficacy of Truqap in combination with Faslodex compared to placebo plus Faslodex in patients with locally advanced or metastatic HR-positive, HER2-low, or negative breast cancer. The study enrolled 708 adults with confirmed HR-positive, HER2-low, or negative breast cancer that had recurred or progressed during or after aromatase inhibitor therapy, with or without a CDK4/6 inhibitor, and up to one line of chemotherapy for advanced disease. The primary endpoints were progression-free survival (PFS) in the overall patient population and in those with PI3K/AKT pathway alterations (PIK3CA, AKT1, or PTEN genes). Approximately 40% of tumors had these alterations, and about 70% of patients had previously received a CDK4/6 inhibitor.

About Truqap

Truqap is a potent adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms (AKT1/2/3). It is administered at a dose of 400mg twice daily on an intermittent schedule of four days on and three days off, selected based on early phase trial results for tolerability and target inhibition.

Truqap has been approved in the US, EU, Japan, and several other countries for treating adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with specific biomarker alterations (PIK3CA, AKT1, or PTEN) following recurrence or progression after endocrine therapy, based on the CAPItello-291 trial results.

It is also approved in Australia for similar indications. Additionally, Truqap is under evaluation in Phase III trials for breast cancer (CAPItello-292) and prostate cancer (CAPItello-280 and CAPItello-281) in combination with established treatments.

AstraZeneca discovered Truqap in collaboration with Astex Therapeutics, which had partnered with the Institute of Cancer Research and Cancer Research Technology Limited.

About Faslodex

Faslodex is an endocrine therapy for ER-positive, locally advanced, or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-estrogen therapy, or disease progression on anti-estrogen therapy.

In the US, EU, and Japan, Faslodex is approved in combination with CDK4/6 inhibitors for treating HR-positive, HER2-negative advanced or metastatic breast cancer that has progressed after endocrine treatment. Faslodex works by blocking and degrading the estrogen receptor, a key factor in disease progression.

Faslodex is approved both as a monotherapy and in combination with other drugs, including CDK4/6, PI3K, and AKT inhibitors, for treating HR-positive advanced breast cancer and is being tested with drugs from other classes.


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