Ariad Pharma Updates Clinical Data On Brigatinib In Patients With ALK+ NSCLC

(RTTNews) - Ariad Pharmaceuticals Inc. (ARIA) announced updated clinical data on its investigational tyrosine kinase inhibitor, brigatinib or AP26113, in patients with anaplastic lymphoma kinase positive or ALK+ advanced non-small cell lung cancer or NSCLC from an ongoing Phase 1/2 trial.

The new results include an analysis of safety and efficacy for patients treated at select doses of brigatinib and an evaluation of intracranial central nervous system or CNS antitumor activity.

The company noted that the updated data on select doses from the Phase 1/2 trial show robust anti-tumor activity of brigatinib in patients with crizotinib-resistant ALK+ NSCLC, with responses now approaching one year.

A separate evaluation of the efficacy and safety of brigatinib in ALK+ NSCLC patients with intracranial CNS metastases at baseline was also presented at the ELCC meeting. In an independent central radiological review of brain Magnetic Resonance Imaging (MRI) scans, 49 of 79 ALK+ NSCLC patients in the Phase 1/2 trial were identified to have intracranial CNS metastases at baseline. Of these 49 patients, 16 had measurable intracranial CNS metastases (15 evaluable) and 33 patients had only non-measurable intracranial CNS metastases (30 evaluable).

A separate, pivotal global Phase 2 trial of brigatinib (AP26113) in patients with locally advanced or metastatic ALK+ NSCLC who have progressed on crizotinib continues to enroll patients. The ALTA (ALK in Lung Cancer Trial of AP26113) trial is designed to determine the safety and efficacy of AP26113 in refractory ALK+ NSCLC patients. The trial will enroll approximately 220 patients including those with brain metastasis. Patients are randomized 1:1 to receive either 90 mg of brigatinib once per day continuously or a lead-in dose of 90 mg/day for 7 days followed by 180 mg/day continuously.

"We are on track for full patient enrollment in the ALTA trial in the third quarter of this year we are encouraged by the CNS anti-tumor activity, now exceeding 18 months in the Phase 1/2 brigatinib trial, and look forward to the evaluation of activity on brain metastasis in the ALTA trial,." said Frank Haluska, senior vice president of clinical research and development and chief medical officer at ARIAD.