AstraZeneca's Truqap Approved by MHRA for Advanced Breast Cancer

AstraZeneca’s (AZ) orally-administered AKT inhibitor, Truqap (capivasertib), has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of certain adults with advanced breast cancer. This approval pertains specifically to patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have at least one alteration in the PIK3CA, AKT1, or PTEN genes and who have not responded to previous anti-hormonal therapies.

In the UK, around 56,800 new cases of breast cancer are diagnosed each year, equating to over 150 diagnoses daily. The progression of HR-positive breast cancer is frequently driven by oestrogen receptors (ERs), and endocrine therapies targeting these ER-driven cancers are commonly administered as a first-line treatment in advanced stages. These therapies are often combined with CDK4/6 inhibitors. However, a significant challenge arises as many patients with advanced disease eventually develop resistance to these treatments, severely limiting further treatment options and reducing survival rates.

Truqap is administered in conjunction with AZ’s endocrine therapy, Faslodex (fulvestrant). It functions by inhibiting the activity of proteins known as ATK kinases, which are crucial for the growth and multiplication of cancer cells. The MHRA's decision to approve Truqap was bolstered by encouraging results from the late-stage CAPItello-291 trial. This trial demonstrated that the combination of Truqap and Faslodex could reduce the risk of disease progression or death by 50% in patients whose tumors exhibited PI3K, AKT pathway, or PTEN alterations, compared to the use of Faslodex alone.

David Harland, the head of oncology medical affairs at AZ UK, emphasized the significance of this new treatment option. He stated that Truqap addresses the unmet needs of HR-positive breast cancer patients with PIK3CA, AKT1, or PTEN altered tumors, who often have limited treatment options due to tumor progression or resistance to endocrine therapies.

This MHRA approval follows closely on the heels of a similar decision by the European Commission. Less than a month ago, the European Commission approved the combination of Truqap and Faslodex for use in adults with ER-positive, HER2-negative locally advanced or metastatic breast cancer. This approval was based on a recommendation from the European Medicines Agency’s human medicines committee. Eligible patients in the EU will also have at least one PIK3CA, AKT1, or PTEN alteration and will be experiencing either disease recurrence or progression on or after an endocrine-based treatment regimen.