Brigatinib Trial Taking Place for ALK-Positive NSCLC Patients

A new milestone was announced in the battle against lung cancer on July 14, 2016, by Virginia Cancer Specialists (VCS) in Fairfax, Va. They reported they have enrolled the first patient in a new advanced lung cancer clinical trial that may hold promise for patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (ALK+ NSCLC).

The randomized phase III clinical trial focuses on brigatinib (AP26113), an investigational anaplastic lymphoma kinase (ALK) inhibitor from ARIAD Pharmaceuticals, Inc, Cambridge, Mass. The trial is designed to assess its efficacy in a head-to-head comparison with the current recommended therapy, crizotinib (Xalkori).  The trial will also evaluate progression-free survival (PFS).

“We are excited to be the very first cancer practice in the world to enroll a patient in this important phase III trial that may eventually lead to improved outcomes for patients battling certain forms of non-small cell lung cancer,” said Alex Spira MD, medical oncologist and director of the VCS Research Institute, in a news release .

The phase III clinical trial of brigatinib was launched in April and it explores the safety and efficacy of brigatinib in patients following crizotinib. The trial will also examine brigatinib’s potential as a new therapy for patients with ALK+ NSCLC who have not yet received an ALK inhibitor.

Brigatinib is currently being evaluated in the global phase II ALTA (ALK in Lung Cancer Trial of AP26113) trial that is anticipated to form the basis for its initial regulatory review.   

Tim Clackson, PhD, who is president of research and development and chief scientific officer of ARIAD, said the encouraging results shown in preclinical and ongoing phase I/II studies suggest brigatinib has the potential to improve outcomes for ALK+ treatment-naïve patients by suppressing ALK+ disease. He said innovative therapies are needed to improve response rates and delay progression that can occur through the emergence of secondary resistance mutations in ALK.

Brigatinib has received breakthrough designation from the US Food and Drug Administration (FDA) and ARIAD recently commenced submission of a New Drug Application (NDA) for initial approval in patients who have experienced crizotinib failure. In June, the FDA cleared brigatinib for an Expanded Access Program (EAP) for patients who have experienced failure of at least one prior ALK inhibitor and cannot meet eligibility criteria for other trials due to a variety of reasons. Those reasons can include poor performance status, lack of geographic proximity, or because other medical interventions are not considered appropriate or acceptable.