Final results for BOLERO-3 trial of Afinitor in Breast Cancer

Novartis presented results from a pivotal Phase III trial (BOLERO-3) of a treatment regimen including Afinitor (everolimus) tablets in women with human epidermal growth factor receptor-2 positive (HER2 positive) advanced breast cancer who received prior taxane therapy and whose disease is resistant to prior trastuzumab (Herceptin) treatment. The findings showed that adding everolimus, an mTOR inhibitor, to trastuzumab and vinorelbine significantly extended progression-free survival (PFS) when compared to treatment with placebo plus trastuzumab and vinorelbine,meeting the study's primary endpoint.

Final PFS results showed that adding everolimus to the standard treatment of trastuzumab and vinorelbine reduced the risk of disease progression by 22% (hazard ratio=0.78 [95% confidence interval (CI): 0.65 to 0.95]; p<0.01). median time to progression was 7.0 months in the everolimus combination arm and 5.8 months in the placebo combination arm. all patients were resistant to trastuzumab-containing regimens and 27% of the patient population was pretreated with a lapatinib-containing regimen. findings on overall survival, the key secondary endpoint of the trial, are not yet mature>

See-O'Regan R. Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Trial of Daily Everolimus Plus Weekly Trastuzumab and Vinorelbine in Trastuzumab-resistant, Advanced Breast Cancer (BOLERO-3). 2013 American Society of Clinical Oncology Annual Meeting. Oral Presentation Abstract No. 505. Presented June 2, 2013.