Novartis (NYSE:NVS) said Tuesday that it met its main goal of a phase three study for Afinitor, a potential drug to treat advanced breast cancer in women.
An interim analysis of the trial showed the tablet drug, in combination with exemestane, significantly extended progression-free survival, or time without tumour growth, when compared to placebo plus exemestane.
The company said the trial was stopped early after results showed the primary endpoint of progression-free survival was met.
The randomized, double-blind study, which involved more than 700 patients at nearly 200 sites around the world, tested post-menopausal women with ER+HER2- metastatic breast cancer, those with an advanced aggresive type of breast cancer whose disease has progressed, despite initial endocrine therapy.
"Despite clinical progress in advanced breast cancer, most women are either initially resistant or develop resistance to endocrine therapy over time," said president of Novartis oncology, Herve Hoppenot.
"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."
Results will be presented at an upcoming medical conference, the company said, and worldwide regulatory submissions are being by planned before year-end.
Novartis' Afinitor targets mTOR in cancer cells, a protein that acts as an important regulator of tumour cell division, blood vessel growth and cell metabolism. The drug is also being tested to treat patients with HER2+ advanced breast cancer.
Afinitor is already approved in the EU and the US for the treatment of advanced kidney cancer.
An interim analysis of the trial showed the tablet drug, in combination with exemestane, significantly extended progression-free survival, or time without tumour growth, when compared to placebo plus exemestane.
The company said the trial was stopped early after results showed the primary endpoint of progression-free survival was met.
The randomized, double-blind study, which involved more than 700 patients at nearly 200 sites around the world, tested post-menopausal women with ER+HER2- metastatic breast cancer, those with an advanced aggresive type of breast cancer whose disease has progressed, despite initial endocrine therapy.
"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."
Results will be presented at an upcoming medical conference, the company said, and worldwide regulatory submissions are being by planned before year-end.
Novartis' Afinitor targets mTOR in cancer cells, a protein that acts as an important regulator of tumour cell division, blood vessel growth and cell metabolism. The drug is also being tested to treat patients with HER2+ advanced breast cancer.
Afinitor is already approved in the EU and the US for the treatment of advanced kidney cancer.
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