Oncology company Ariad Pharmaceuticals announced that its investigational drug AP26113 has been designated Breakthrough Therapy status by the U.S. Food and Drug Administration (FDA) as treatment for crizotinib-resistant patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC).
AP26113 is an oral ALK inhibitor being developed as treatment for lung cancer, sarcomas, neuroblastomas, and lymphomas. The drug has been designed to overcome mutation-based resistance that could lead to relapse of disease. Non-small cell lung cancer is the leading form of lung cancer; indeed, NSCLC accounts for 85 percent of lung cancer cases diagnosed every year in the U.S.
Harvey J. Berger, Chairman and CEO of ARIAD, said, “We are very pleased that the FDA has granted Breakthrough Therapy designation to AP26113. We are encouraged by the clinical data on AP26113 that were presented recently at the European Cancer Congress, particularly in patients whose tumor had spread to the brain.” Berger said that the company is still driving patient enrollment in the ALTA trial. Ariad also intends to conduct a front-line trial of the drug in patients who have not yet undergone treatment.
The Breakthrough Therapy designation is based on positive results from the current Phase 1/2 trial that showed AP26113 held its own fighting tumors in patients with lung cancer, including those with active brain metastases. The results were presented at the recent 2014 European Cancer Congress.
Scott N. Gettinger, associate professor of medicine at Yale School of Medicine, commented, “The updated data from the ongoing trial continue to demonstrate the anti-tumor activity of AP26113 in patients with crizotinib-resistant ALK rearranged NSCLC, as well as TKI-naïve ALK rearranged NSCLC. One of the distinguishing features of the data is the evidence for anti-tumor activity in the brain, a common site of treatment failure.”
This month, the company also announced the restructuring of its agreement with Bellicum Pharmaceuticals for Ariad’s cell signaling technology.