Novartis' Afinitor trial does not demonstrate statistical significance in HER2-positive breast cancer

15 December 2014

Swiss pharma major Novartis (NOVN: VX) says that its BOLERO-1 trial of Afinitor (everolimus) in combination with Herceptin (trastuzumab) and paclitaxel as first-line treatment in HER2-positive advanced breast cancer did not demonstrate statistically significant benefits.

The HER2-positive breast cancer population represents around 20% of all advanced breast cancer and differs from hormone receptor-positive/human epidermal growth factor 2-negative breast cancer, for which Afinitor and exemestane following a non-steroidal aromatase inhibitor is approved worldwide.

This study did not meet the threshold of statistical significance for the primary objectives of demonstrating progression-free survival among HER2-positive advanced breast cancer, or the pre-defined hormone-receptor negative, human epidermal growth factor receptor 2-positive subgroup.

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