Novartis Posts Afinitor Results In HER2+ Breast Cancer

Novartis reported results from the BOLERO-1 trial of its drug Afinitor (everolimus) as combination therapy with Herceptin (trastuzumab) and paclitaxel as first-line treatment in HER2+ advanced breast cancer at the 2014 San Antonio Breast Cancer Symposium (SABCS). 

Afinitor targets the PI3K/AKT/mTOR pathway, which is typically hyperactivated in several cancer types. Through its mechanism of action, Afinitor helps stop tumors from developing and spreading. The drug has received approval from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as treatment for renal cell carcinoma and neuroendocrine tumors originating in the pancreas. 

The randomized, placebo controlled, double-blind BOLERO-1 (Breast cancer trials of OraL EveROlimus-1) study investigated Afinitor in women with human epidermal growth factor receptor-2 positive HER2+ locally advanced or metastatic breast cancer. Results showed that though everolimus with trastuzumab and paclitaxel achieved greater median progression-free survival (PFS), it was not significant compared to placebo plus trastuzumab and paclitaxel (15.0 months vs. 14.5 months). 

The drug however, demonstrated benefit over the placebo arm in the trial’s second primary endpoint. In the HR- subgroup of women with HER2+ advanced breast cancer, Afinitor plus trastuzumab and paclitaxel treatment prolonged median PFS by 7.2 months compared to the placebo arm (20.3 months vs. 13.1 months). However, the company only considered this data clinically relevant, rather than statistically significant. 

Alessandro Riva, Global Head of Oncology Development and Medical Affairs at Novartis Oncology, said, “For more than two years, Afinitor has positively impacted the HR positive treatment landscape as an important therapy for women living with advanced breast cancer. …We thank all of the researchers and patients who participated in the BOLERO-1 study.” 

Novartis said the results, though far from what it expects as strong findings, support its continued research of the PI3K/AKT/mTOR pathway in advanced breast cancer. 

Earlier this year, Novartis announced positive results from the Phase 3 BOLERO-2 (breast cancer trials of ra velimus-) study of Afinitor plus exemestane in hormone receptor-positive advanced breast cancer.