Interim results from an ongoing Phase II clinical trial of neratinib were presented at the 2014 San Antonio Breast Cancer Symposium (SABCS).

Neratinib is an investigational, oral medication that targets HER2 as well as HER4 and the epidermal growth factor receptor (EGFR). Twenty to 25 percent of breast cancers overexpress (make too much of) a protein known as HER2. Overexpression of this protein leads to increased growth of cancer cells and a worse breast cancer prognosis. The development of targeted therapy drugs such as Herceptin® (trastuzumab) that target HER2-positive cells has improved prognosis for women with HER2-positive breast cancer. Neratinib, like Tykerb® (lapatnib), and Gilotrif® (afatinib) is a dual inhibitor of HER2 and EGFR kinases.

To evaluate neratinib in the treatment of advanced, HER2-positive breast cancer, researchers conducted a phase II clinical trial administering neratinib in combination with the anticancer drug Torisel™ (temsirolimus) in patients with HER2-positive metastatic breast cancer.

Patients in this clinical study were heavily pretreated, having failed an average of 3 prior treatment regimens in the metastatic before entering the trial.

The interim safety results of the study showed that the most frequently observed side effect for the patients who received the combination of neratinib plus temsirolimus was diarrhea. Overall approximately 30% of patients receiving the combination achieved at least a partial disappearance of their cancer.

The phase II clinical study clearly demonstrates that neratinib has significant anti-cancer activity in patients with HER2-positve breast cancer. Continued development of neratinib in clinical trials is ongoing to determine its role in the management of breast cancer.

Reference: Gajria D, Modi S, Saura C, et al. A phase I/II study of neratinib plus temsirolimus in HER2+ metastatic breast cancer reveals ongoing HER2 pathway dependence in many patients despite several lines of HER2 targeted therapy. Presented at the 2014 San Antonio Breast Cancer Symposium, December 9-13, 2014. San Antonio, Texas. Abstract P5-19-04.

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