Novartis has announced that Piqray (alpelisib) has been recommended by the National Institute for Health and Care Excellence (NICE) for use in combination with Faslodex (fulvestrant) for the treatment of advanced breast cancer patients.
The recommendation follows the ‘consistent, significant improvements’ in median progression-free survival and overall response rates when using Piqray in combination with Faslodex.
Breast cancer is the most common type of cancer in the UK, with around 55,000 women diagnosed each year, and endocrine resistance affecting approximately 40% of HR+/HER2- advanced breast cancer patients.
Commenting on the recommendation, Nicolò Battisti, medical oncologist at The Royal Marsden NHS Foundation Trust, said: “NICE’s recommendation is an important development in the treatment of advanced breast cancer, an area where there is an urgent need for innovation to improve clinical and patient outcomes.
“Targeted therapies addressing genomic mutations such as PIK3CA mutations are advancing the treatment options we have available for our patients. Considering alpelisib [Piqray] involves identifying this specific genomic biomarker via a test, determining who is eligible for this new treatment option and potentially giving them a chance to live longer and live well in the context of an advanced breast cancer diagnosis.”
The treatment will be available immediately through the interim Cancer Drugs Fund (CDF), with testing for variants in the gene accessible through the National Genomic Test Directory in England and Wales.
Around 2,800 specific breast cancer patients in England and Wales could benefit from the treatment, including postmenopausal women, and men, with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), PIK3CA-mutated locally advanced or metastatic breast cancer, that has progressed after endocrine and CDK4/6 inhibitor therapy.
PIK3CA mutations are a driver of developing endocrine resistance, a significant concern in the treatment of advanced breast cancer, and may lead to faster disease progression for patients, and a worse prognosis.
Piqray was approved by the European Medicines Agency (EMA) in July 2020 for use in combination with Faslodex for advanced breast cancer patients with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy, but the licence did not include patients that have received prior endocrine and CDK4/6 inhibitor combination treatment.
The treatment is also under review by the Scottish Medicines Consortium (SMC) in Scotland and a decision expected later this year.