20 May 2013 - 20 May 2013 - Swiss pharmaceutical group Novartis (VTX:NOVN) said Friday that a Phase III study of its tablets Afinitor (everolimus) plus US Genentech's Herceptin (trastuzumab) and vinorelbine in HER2 positive (HER2+) advanced breast cancer had met its primary objective of extending progression-free survival (PFS).

Everolimus targets the PI3K/AKT/mTOR pathway.

The randomised, double-blind trial, called BOLERO-3, evaluated everolimus 5 mg/day orally or placebo, plus weekly vinorelbine 25 mg/m2 IV and weekly trastuzumab 2 mg/kg IV following loading dose of 4 mg/kg in 569 patients with HER2+ locally advanced or metastatic breast cancer who were previously treated with a taxane and were resistant to trastuzumab. The primary goal of the study was PFS, while the secondary ones were overall survival, objective response rate, time to deterioration of performance status, changes in quality-of-life scores over time, clinical benefit rate, duration of response, time to response, safety and pharmacokinetics.

Everolimus is cleared in the EU as a therapy of hormone receptor-positive, HER2 negative (HR+/HER2 negative) advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. In the USA, the drug is authorised for the treatment of postmenopausal women with advanced HR+/HER2 negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole.

Genentech is part of Swiss Roche (VTX:ROG).