The phase III study showed that Afinitor (everolimus), in combination with hormonal therapy Aromasin (exemestane), increased progression free survival in women with advanced breast cancer.
The BOLERO-2 study also included women with estrogen receptor+ (ER+) HER2 metastatic breast cancer whose disease has progressed, despite initial endocrine therapy.
The trial was stopped early due to the drug meeting its primary endpoint of extending patients’ time without tumour growth.
Hervé Hoppenot, president of Novartis Oncology, said: “Despite clinical progress in advanced breast cancer, most women are either initially resistant or develop resistance to endocrine therapy over time. As a result, there is a significant need for new treatment options.
“Based on these study results, this combination has the potential to extend the time until chemotherapy is needed for these patients.”
Afinitor is already licenced in the US to treat benign brain tumours (SEGA), a type of renal cancer, and for the prevention of some organ rejections, bringing in sales of $243 million last year. In Europe the drug’s SEGA licence was recommended for approval last month and if passed it will be marketed as
Votubia.
Full results from the BOLERO-2 trial will be presented at an upcoming medical conference, with the Swiss pharma firm saying it will seek global regulatory filings by the end of the year.
Ben Adams