Novartis' Afinitor may overcome Herceptin resistance; Ph I study

New data from two early-stage clinical studies show that Novartis' Afinitor (everolimus) may overcome resistance to Herceptin (trastuzumab) in women with HER2-positive metastatic breast cancer. According to the Swiss drug major, these results support the initiation of a Phase III trial program to fully explore the potential of the agent, also known as RAD001, in breast cancer.

Two Phase I studies presented at this year's San Antonio Breast Cancer Symposium show that the combination of Afinitor plus Roche's Herceptin and weekly Taxol (paclitaxel) halted tumor growth in 77% of patients with HER2-positive metastatic breast cancer with documented resistance to Herceptin. In addition, the data demonstrated the first complete response in the trial.

Updated findings from the second Phase I study show promising anticancer activity for Afinitor in combination with Herceptin and Japanese drugmaker Kyowa Hakko Kogyo's Navelbine (vinorelbine) in heavily-pre-treated Herceptin-resistant patients with HER2-positive metastatic breast cancer. In the study, Afinitor plus Herceptin and Navelbine halted tumor growth in 62% of patients.