The FDA has granted seribantumab (Merrimack Pharmaceuticals) fast track status for development in patients with heregulin-positive, locally advanced or metastatic non–small-cell lung cancer (NSCLC) whose disease has progressed after immunotherapy. The global SHERLOC trial is evaluating seribantumab in combination with docetaxel or pemetrexed in heregulin-positive patients with NSCLC. The data from this study will be used to support a biologics license application to the FDA.
The FDA’s fast track program was designed to facilitate and expedite the development and review of drugs that treat serious conditions and fill an unmet medical need.
Seribantumab is a fully human anti-ErbB3 monoclonal antibody that targets phenotypically distinct heregulin-positive cancer cells within solid tumors. Heregulin-positive cancer cells are characterized by their ability to escape the effects of targeted cytotoxic and antiendocrine therapies and to potentially contribute to rapid clinical progression in patients whose tumor cells test positive for heregulin, as detected by RNA in situ hybridization (RNA-ISH). When used in the combination setting, seribantumab is designed to block the heregulin/ErbB3 signaling axis in order to make these cells accessible to the effects of the combination therapy.
Heregulin-positive disease has been linked to rapid progression and poor prognosis in multiple types of cancer, including NSCLC. The higher the prevalence of heregulin-positive cancer cells in a tumor, the lower the antitumor effect of the chemotherapy. Clinical data have shown that standard-of-care therapy may be more effective and result in improved patient outcomes when combined with seribantumab.
Lung cancer is the leading cause of cancer-related death in the United States. The American Cancer Society estimates that approximately 224,000 new cases of lung cancer (both small-cell lung cancer and NSCLC) will be reported in 2016, 83% of which will be NSCLC. Approximately 101,000 NSCLC patients in the United States have heregulin-positive tumors.
Source: Merrimack Pharmaceuticals; July 6, 2016.