ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced the initial clinical results on its investigational, tyrosine-kinase inhibitor, AP26113, in patients with advanced non-small cell lung cancer (NSCLC) from an ongoing Phase 1/2 trial. The study provides compelling clinical evidence of the anti-tumor activity of AP26113 at multiple dose levels in patients with anaplastic lymphoma kinase positive (ALK+) NSCLC and initial clinical evidence of anti-tumor activity in patients with epidermal growth factor receptor mutant (EGFR-m) NSCLC. The results are being presented this morning at the ESMO 2012 Congress of the European Society for Medical Oncology being held in Vienna, Austria.
Patients enrolled in the trial have advanced solid tumors that were refractory to available therapies or had no standard or curative treatment available to them. The primary objectives of the Phase 1 portion of the trial are to determine the maximum tolerated dose (MTD) and the recommended dose for further study of AP26113 and to characterize its safety and preliminary anti-tumor activity. The trial uses an open-label, dose-escalating design. Anti-tumor activity was determined by serial CT scans using RECIST criteria.
Thirty-four patients have been enrolled to date in the study in six dose-cohorts ( i.e., 30, 60, 90, 120, 180 and 240 mg administered orally once daily). Nineteen patients currently remain on study, with 16 at the three highest dose levels.
Twenty-nine of the patients enrolled to date in the study have NSCLC: 14 who are ALK+ and 11 who are EGFR-m. More than two-thirds of these patients failed three or more regimens of prior treatment, including both targeted therapies and chemotherapy.“The initial findings from this ongoing study show that AP26113 has impressive anti-tumor activity in ALK+ NSCLC patients, who are either naïve or resistant to crizotinib,” stated Scott Gettinger, M.D., Associate Professor of Medicine at Yale School of Medicine, the study’s presenter at ESMO. “At the same time, it is encouraging to see a partial response in a patient with EGFR-mutant lung cancer and acquired resistance to erlotinib in the Phase 1 dose-escalation portion of the trial.”