Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) has revealed that it has launched a randomized fist –line phase 3 trials for an experimental anaplastic lymphoma kinase (ALK) inhibitor called brigatinib.
The drug trial will involve patients who have been diagnosed with ALK and whose condition has advanced or patients with metastatic non-small cell lung cancer (NSCLC) and have not previously been subjected to any treatment using an ALK inhibitor. The new trial has been engineered to determine the efficiency of the brigatinib compared to crizotinib, and the scientists will determine the results based on the primary endpoint of progression-free survival (PFS).
ARIAD’s chief scientific officer and president of R&D Tim Clackson, Ph.D. stated that the company was excited about the advancement of the treatment to the phase 3 trials. He also added that the phase is important because it will help the firm determine its viability as a treatment for patients with ALK+ NSCLC and have never received treatment using an ALK inhibitor. Dr. Clackson also pointed out that the encouraging results from the ongoing phase 1 and phase 2 trials suggest that the drug has the potential to improve the conditions of the ALK+ NSCLC patients. This is in comparison with the results from crizotinib treatment on patients with the same condition.
The trial will be carried out in 150 research sites in the Asia-Pacific region, Europe, and North America. About 270 patients will receive the treatment in which 90 mg will be administered orally on a daily basis for seven days. Patients will then receive a 180 mg single dose every day after the seven days. The company hopes to complete the trial period in 2018.
Scientists and doctors conducting the study expect the primary end point of the trial to result in progression-free survival (PFS), and the criteria will be evaluated by a blinded Independent Review Committee (BIRC). The firm will also carry out tumor response assessments after every eight weeks. The secondary endpoints include overall survival, objective response rate, safety, and tolerability, intracranial PFS, intracranial ORR and duration of response.