AstraZeneca’s (AZ) orally-administered AKT inhibitor Truqap (capivasertib) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat a subset of adults with advanced breast cancer.
Patients eligible for the therapy will have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with at least one PIK3CA, AKT1 or PTEN alteration and will have not responded to other anti-hormonal-based therapies.
Approximately 56,800 new cases of breast cancer are diagnosed in the UK each year, equating to more than 150 every day.
The growth of HR-positive breast cancer progression is often driven by oestrogen receptors (ERs), and endocrine therapies that target ER-driven disease are widely used as a first-line treatment in the advanced setting and often paired with CDK4/6 inhibitors. However, resistance to these therapies develops in many patients with advanced disease, at which point treatment options are limited and survival rates are low.
Truqap is given alongside AZ’s endocrine therapy Faslodex (fulvestrant) and works by blocking the effects of proteins called ATK kinases, which allow cancer cells to grow and multiply.
The MHRA’s decision is supported by positive results from the late-stage CAPItello-291 trial, in which Truqap plus Faslodex reduced the risk of disease progression or death by 50% compared with Faslodex alone in patients with tumours harbouring PI3K, AKT pathway or PTEN alterations.
David Harland, oncology medical affairs head, AZ UK said: “[Truqap] is a new treatment option which addresses the unmet needs of eligible HR-positive breast cancer patients with PIK3CA, AKT1, or PTEN altered tumours.
“These patients may often face limited options due to tumour progression or resistance to endocrine therapies.”
The approval comes less than a month after the European Commission approved the Truqap/Faslodex combination for use in adults with ER-positive, HER2-negative locally advanced or metastatic breast cancer, following a recommendation from the European Medicines Agency’s human medicines committee.
Patients eligible for the therapy in the EU will also have at least one PIK3CA, AKT1 or PTEN alteration and will be experiencing disease recurrence or progression on or after an endocrine-based regimen.