Ariad Initiates Pivotal Phase 2 ALTA Trial Of AP26113 In Patients With NSCLC

(RTTNews) - Ariad Pharmaceuticals Inc. (ARIA) announced the initiation of a pivotal global Phase 2 trial of AP26113 in patients with locally advanced or metastatic non-small cell lung cancer or NSCLC who were previously treated with crizotinib.

The ALTA (ALK in Lung Cancer Trial of AP26113) trial is designed to determine the safety and efficacy of AP26113 in refractory NSCLC patients who test positive for the anaplastic lymphoma kinase (ALK+) oncogene.

Approximately 220 patients with ALK+ NSCLC who have been treated with and progressed on their most recent crizotinib therapy will be randomized one-to-one to receive either 90 mg of AP26113 once per day (QD) continuously, or a lead-in dose of 90 mg QD for seven days followed by 180 mg QD continuously.

The primary endpoint of the ALTA trial will be objective response rate (ORR) as measured by RECIST criteria. Secondary endpoints include time to response, duration of response, disease control rate, progression-free survival, overall survival, safety, and tolerability. Health related quality of life will also be assessed. In patients who have active brain metastases, central nervous system response will also be measured.

The company stated that the ALTA trial will be conducted in patients with advanced NSCLC who have ALK rearrangement documented by fluorescence in situ hybridization or FISH. The trial will be randomized to independently examine the overall response rate for each dose level. Patients will be stratified by response to prior therapy and by the presence or absence of active brain metastases. The study is designed to have approximately a 90% power to rule out an uninteresting ORR of 20%, when the true rate is 35% or higher.

Full patient enrollment in the ALTA trial is expected in the third quarter of 2015, and final data analysis will be performed when patients have completed six months of AP26113 treatment. ARIAD expects to report first data from the trial at a medical meeting in 2015.

The ALTA trial is expected to enroll patients at approximately 100 cancer centers in the United States, Europe, Canada and Asia.