Novartis Afinitor Pivotal Phase 3 Trial Shows Significant Delay in Tumor Growth In HER2 Positive Advanced Breast Cancer

Novartis International AG

/ Novartis pivotal Phase III trial shows Afinitor® significantly delays tumor growth in HER2 positive advanced breast cancer . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement. A 22% reduction in the risk of disease progression was seen with the addition of everolimus, an mTOR inhibitor, to trastuzumab and vinorelbine in heavily pretreated patients[1]  First Phase III study showing that inhibition of HER2 positive receptor and mTOR provides significant benefit in HER2 positive advanced breast cancer[1]  Everolimus is currently approved as Afinitor in more than 65 countries for the treatment of HR+/HER2 negative advanced breast cancer[2]   Basel, June 2, 2013 - Novartis today presented results from a pivotal Phase III trial 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[1]. The