Capivasertib approved for advanced breast cancer in the UK

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved AstraZeneca’s capivasertib (Truqap) for patients with advanced hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer. It is approved in cancers that have one or more abnormal PIK3CA, AKT1, or PTEN gene, and does not respond to other anti-hormonal-based therapies. Capivasertib is an AKT inhibitor, which blocks the effects of ATK kinases that enable cancer cell growth and multiplication. By blocking their action, capivasertib can reduce the growth and spread of the advanced breast cancer and help to destroy cancer cells. Capivasertib is given in combination with fulvestrant, a hormonal therapy for the treatment of advanced breast cancer. The application for approval was supported by evidence obtained via a clinical trial of 708 patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer, of which 289 patients had tumours with an abnormal PIK3CA, AKT1 or PTEN gene. During clinical trials, patients given capivasertib experienced an average 7.3 months with the cancer not progressing versus 3.1 months for patients who were given placebo. Professor Nicholas Turner, Professor of Molecular Oncology at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, who led the CAPItello-291 trial, said: “This is a wonderful development in the treatment of the most common type of advanced breast cancer. Around half of patients with this kind of breast cancer have mutations in one or more of the genes – PIK3CA, AKT1 or PTEN, and for these patients, capivasertib provides an exciting, new targeted treatment which can keep their cancer from progressing for longer. We hope NICE will recommend the use of capivasertib in combination with fulvestrant for patients on the NHS.” EU approval for capivasertib In June 2024, capivasertib was approved in combination with Faslodex (fulvestrant) in the European Union for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. In clinical trials, the combination treatment reduced the risk of disease progression or death by 50% versus Faslodex in combination with placebo in patients with tumours harbouring PI3K, AKT or PTEN alterations. Mafalda Oliveira, Vall d’Hebron University Hospital, and Senior Clinical Investigator of the Vall d’Hebron Institute of Oncology’s Breast Cancer Group in Barcelona, Spain, said: “Today’s approval is welcome news for approximately half of ER-positive breast cancer patients in Europe who have tumours with these biomarkers, and it is important for clinicians to test and identify eligible patients who may be able to benefit from this combination.” Diana Spencer, Senior Digital Content Editor, DDW