Fairfax, Va. (July 14, 2016) — Virginia Cancer Specialists (VCS), Virginia’s premier cancer care center with more than 40 years of providing service to patients battling cancer and blood diseases, is the first in the world to enroll a 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, an investigational anaplastic lymphoma kinase (ALK) inhibitor from ARIAD Pharmaceuticals, Inc. The trial is designed to assess the efficacy of the drug candidate in a head-to-head comparison with the current recommended therapy, crizotinib, evaluating progression free survival.

Virginia Cancer Specialists conducts clinical trials through US Oncology Research, one of the largest community-based cancer research programs in the country. US Oncology Research has played a role in approximately 60 FDA approved cancer therapies, nearly one-third of all approved cancer therapies to date. Other practices affiliated with US Oncology Research are also participating in the trial. The trial is expected to be conducted at approximately 150 investigational sites in North America, Europe and the Asia Pacific region.

“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 M.D., medical oncologist and director of the VCS Research Institute. “As the leader in clinical research in Northern Virginia, we are committed to advancing the fight against cancer by bringing cutting-edge clinical trials, like the brigatinib study, to our region, providing patients access to novel investigational therapies in a convenient community setting. Rather than traveling elsewhere for these advanced investigational treatments, patients can receive care in a comfortable, familiar environment close to home where they have the ongoing support of family and friends, helping them achieve the best possible outcome.”
The Phase III clinical trial of brigatinib was launched in April, and the VCS Research Institute immediately began screening patients for eligibility, eventually identifying the patient who would become the very first in the world to enroll in this advanced clinical study.

“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.” said Tim Clackson, Ph.D., president of research and development and chief scientific officer of ARIAD. “We believe that the encouraging results shown in our preclinical and ongoing Phase I and II studies suggest brigatinib has the potential to improve outcomes for ALK+ treatment-naïve patients by suppressing ALK+ disease.”

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