Ariad Pharmaceuticals Inc fka ARIA

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Evidence Supports AP26113 in Patients with Non–Small Cell Lung Cancer With Brain Metastases, by Alice Goodman, The ASCO Post, December 1, 2013, Volume 4, Issue 19

Tapered dose steroids were used to resolve symptoms over 1 week, and patients restarted the drug at 90 mg/d without further pulmonary symptoms, he said. Future studies will employ a step-up approach, initiating the drug at 90 mg/d for 7 days before moving up to 180 mg/d.

AP26113 was generally well tolerated. Common adverse events of all grades were nausea (38%), fatigue (34%), and diarrhea (32%); 12% had elevated liver enzymes. Treatment-emergent grade 3 or higher adverse events were reported in 2% to 4% across all dose levels, and included dyspnea, fatigue, diarrhea, hypoxia, and pneumonitis. Pulmonary events, which occurred early in 3/25 patients at the 180-mg/d level and seemed to be rarer at lower doses, were responsive to drug interruption, although resolution, despite continued dosing, was also reported. Future studies will employ a step-up approach, initiating the drug at 90 mg/d for 7 days before moving up to 180 mg/d.

AP26113 had robust antitumor activity in crizotinib-resistant and crizotinib-naive NSCLC patients, including those with brain metastasis after crizotinib treatment.

“Most if not all patients with NSCLC will become resistant to crizotinib, and half of those who are resistant have brain metastasis,” explained lead author D. Ross Camidge, MD, PhD, Associate Professor and Director of the Thoracic Oncology Clinical Program at University of Colorado, Denver.