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Ariad Pharmaceuticals Inc Announces Phase 1 Data on AP26113 in Patients with Non-Small Cell Lung Cancer


Sunday, 2 Jun 2013 09:00am EDT 

Ariad Pharmaceuticals Inc announced updated clinical results on its investigational tyrosine kinase inhibitor (TKI), AP26113, in patients with advanced non-small cell lung cancer (NSCLC) from an ongoing Phase 1/2 trial. The study confirms compelling clinical evidence of the anti-tumor activity of AP26113 at multiple dose levels in patients with anaplastic lymphoma kinase positive (ALK+) NSCLC, including brain metastases, and initial clinical evidence of anti-tumor activity in patients with epidermal growth factor receptor mutant (EGFRm) NSCLC. The study identified a recommended Phase 2 dose of 180 mg administered orally once daily. The Phase 2 portion of trial is now open and enrolling patients at this dose in the first four expansion cohorts. Further Phase 1 evaluation of the 240 mg dose is continuing in NSCLC patients with documented EGFRm and the secondary mutation, T790M, following disease progression on prior EGFR TKI therapy. Patients enrolled in Phase 1 portion of the trial had advanced solid tumors that were refractory to available therapies or had no standard or curative treatment available. The objectives of the Phase 1 portion of the trial were to determine the recommended dose for further study of AP26113 and to characterize its safety (including the maximum tolerated dose, MTD), pharmacokinetics, and preliminary anti-tumor activity. The trial used an open-label, dose-escalating design. Anti-tumor activity was determined by serial CT scans using RECIST criteria. 

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