Piqray and Faslodex combo extends survival in HR+/HER2-, PIK3CA+ advanced breast cancer at ESMO 2020

pharmafile | September 21, 2020 | News story | Research and Development, Sales and Marketing Cancer, ESMO 2020, Novartis, pharma 

New data has been unveiled for the combination of Novartis’ Piqray (alpelisib) with AstraZeneca’s Faslodex (fulvestrant) in the treatment of hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer in patients whose tumours are PIK3CA positive. So far, Piqray is the only therapy approved in the US and Europe, as well as 15 other countries, to treat this indication.

The data, revealed at the European Society for Medical Oncology Virtual Congress 2020, showed that the combo improved overall survival (OS) rates by eight months compared to those receiving Faslodex alone, with a median recorded OS of 39.3 months with Piqray and Faslodex together compared to 31.4 months with Faslodex monotherapy.

In patients whose cancer had metastasised to the lungs or liver, this OS benefit grew to more than 14 months, with a median OS of 37.2 months with the combo versus 22.8 months with Faslodex alone.

Additionally, the time until patients required chemotherapy was delayed by nine months in those taking the combo, for a total of 22.3 months compared to 14.8 months with Faslodex monotherapy.

Dr Susanne Schaffert, President of Novartis Oncology said: “These data demonstrating survival benefit give the 40% of HR+/HER2- advanced breast cancer patients with PIK3CA mutations in their tumours more time to spend with loved ones and do what they value most.”

However, the trial investigators noted that the study’s second endpoint of OS in patients with PIK3CA-mutated breast cancer did not reach statistical significance.

Matt Fellows

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