The first patient has been enrolled in the Phase III clinical trial of brigatinib, an investigational anaplastic lymphoma kinase (ALK) inhibitor from ARIAD Pharmaceuticals.
The Phase III trial of brigatinib commenced in April, and the Virginia Cancer Specialists Research Institute started screening patients for eligibility, eventually identifying a patient who became the first to be enrolled in this clinical study.
The new advanced lung cancer clinical trial may hold promise for patients suffering with ALK-positive locally advanced or metastatic non-small-cell lung cancer (ALK+ NSCLC).
The trial is intended to determine the efficacy of the drug candidate in a head-to-head comparison with the present recommended therapy, crizotinib and progression free survival.
Along with Virginia Cancer Specialists, other practices affiliated with US Oncology Research are also participating in the trial.
This trial is expected to be conducted at around 150 investigational sites in North America, Europe and the Asia Pacific region.
US Oncology Research is a community-based cancer research programme.
ARIAD chief scientific officer and research and development president Tim Clackson said: “Our pivotal trial of brigatinib explored its safety and efficacy for patients following crizotinib.
“Virginia Cancer Specialists and other clinical trial sites are also examining brigatinib’s potential as a new therapy for patients with ALK+ NSCLC who have not yet received an ALK inhibitor.
“Innovative therapies are needed for these patients to improve response rates and delay progression that can occur through the emergence of secondary resistance mutations in ALK, and progression in the central nervous system.”
Brigatinib has secured breakthrough designation from the US Food and Drug Administration (FDA), and recently, ARIAD commenced submission of a New Drug Application for initial approval in patients who have experienced crizotinib failure.
Last month, the regulatory authority cleared brigatinib for an expanded access programme (EAP), a programme that enables manufacturers to provide investigational new drugs to patients with serious diseases.