EC Approves AstraZeneca’s Truqap plus Faslodex for Advanced Breast Cancer

AstraZeneca’s (AZ) AKT inhibitor Truqap (capivasertib) and its endocrine therapy Faslodex (fulvestrant) have received approval from the European Commission (EC) for combined use in treating a specific group of adults with advanced breast cancer. This combination treatment is designated for patients with oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer that exhibits at least one alteration in the PIK3CA, AKT1, or PTEN genes. These patients must have experienced disease recurrence or progression following an endocrine-based regimen.

The EC's decision was influenced by a recent recommendation from the European Medicines Agency and is underpinned by encouraging outcomes from the late-stage CAPItello-291 trial. In this trial, the combination of Truqap and Faslodex showed a 50% reduction in the risk of disease progression or death compared to using Faslodex alone in patients whose tumours had PI3K, AKT pathway, or PTEN alterations.

Breast cancer remains the foremost cause of cancer deaths in Europe, with over 550,000 new cases diagnosed in 2022 alone. The progression of hormone receptor-positive (HR-positive) breast cancer is frequently driven by oestrogen receptors (ERs). Endocrine therapies targeting ER-driven disease are commonly employed as a first-line treatment in advanced cases and are often combined with CDK4/6 inhibitors. However, many patients with advanced breast cancer eventually develop resistance to these therapies, significantly limiting treatment options and reducing survival rates.

Dave Fredrickson, executive vice president of AZ’s oncology business unit, emphasized that Truqap is now the first and only AKT inhibitor approved in the EU for patients with ER-positive breast cancer with PIK3CA, AKT1, or PTEN alterations. He described the approval as a significant advancement in offering a new and innovative treatment option for patients who are in dire need of new therapies.

Just days prior to this authorisation, AZ received approval from the US Food and Drug Administration (FDA) for its drug Imfinzi (durvalumab) as part of a combination therapy for a subset of endometrial cancer patients. The approved regimen involves Imfinzi combined with carboplatin and paclitaxel, followed by Imfinzi monotherapy. This treatment is now authorised for adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient.

These recent approvals highlight AZ’s ongoing efforts to expand its oncology portfolio and provide new treatment options for patients with various types of advanced cancer. The approvals also underscore the importance of targeted therapies in improving outcomes for patients with specific genetic alterations in their tumours.