Center Enrolls First Lung Cancer Patient in Advanced Phase 3 Clinical Trial

Center Enrolls First Lung Cancer Patient in Advanced Phase 3 Clinical Trial

For 40 years, Virginia Cancer Specialists (VCS) has contributed to the campaign against cancer and diseases of the blood by offering advanced technology, treatment and early detection. For residents of Northern Virginia this means the chances of beating cancer are better than ever.

The center has now enrolled the first patient in an advanced lung cancer study that holds promise for patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (ALK+ NSCLC).

The Phase 3 clinical trial will investigate the efficacy of brigatinib (AP26113), an anaplastic lymphoma kinase (ALK) inhibitor from Ariad Pharmaceuticals, compared to crizotinib, the current recommended therapy. The primary endpoint of the trial is the assessment of progression-free survival.

VCS conducts clinical trials through U.S. Oncology Research, a cancer program that played a role in about 60 FDA-approved cancer therapies. Other practices affiliated with U.S. Oncology Research are also participating in the clinical trial, which is expected to be conducted at 150 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 3 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 press release.

“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,” he said. “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.”

In April 2016, Ariad initiated the Phase 3 ALTA 1L clinical trial assessing brigatinib in adult patients with ALK-positive locally advanced or metastatic NSCLC, who have not previously been treated with an ALK inhibitor. At that time, VCS Research Institute began screening patients for eligibility, and identified the first patient in the world to enroll in the trial.

“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,” said Tim Clackson, PhD, Ariad’s president of research and development and chief scientific officer.

“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,” Clackson said. “We believe that the encouraging results shown in our preclinical and ongoing Phase 1 and 2 studies suggest brigatinib has the potential to improve outcomes for ALK+ treatment-naive patients by suppressing ALK+ disease.”

The U.S. FDA granted orphan drug status to brigatinib in May 2016 for the treatment of certain subtypes of NSCLC. The designation is for ALK positive, c-ros 1 oncogene positive (ROS1+), or epidermal growth factor receptor positive (EGFR+) NSCLC.

Previously, in October 2014, Brigatinib had received breakthrough therapy designation from the FDA for the treatment of patients with ALK+ NSCLC whose disease is resistant to crizotinib.

Both designations were based on results from a Phase 1/2 trial that showed anti-tumor activity of brigatinib in patients with ALK+ NSCLC, including patients with active brain metastases.

Ariad has plans to submit an FDA new drug application for initial approval of brigatinib in patients who have experienced crizotinib failure.

In June 2016, an Expanded Access Study on brigatinib was started. The purpose of the Expanded Access Program (EAP) is to provide brigatinib for patients with locally advanced and/or metastatic ALK+ NSCLC on expanded access basis due to their inability to meet eligibility criteria for ongoing recruiting trials, inability to participate in other clinical trials (such as poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.

“Lung cancer is the leading cause of cancer-related deaths in the United States and is extremely difficult to treat because there are so many different mutations,” said Raymond Wadlow, MD, medical oncologist and co-director of the VCS Research Institute. “The brigatinib Phase 3 clinical trial may eventually provide a potential new therapy for patients with ALK+ NSCLC, an area where more innovative therapies are desperately needed to improve response rates.

“Meanwhile, the Expanded Access Program will give another option to patients who have experienced failure of another TKI, offering the potential opportunity for improved outcomes to patients who are battling this complex disease,” Wadlow added.

Patients 18 years or older with locally advanced and/or metastatic ALK+ NSCLC who are interested in participating in the clinical trial or Expanded Access Program for brigatinib can contact the VCS Research Institute at 703-208-3192 to learn more about the criteria for participation.

Karin Choquette, MSN, RN, CCRC, clinical research manager at VCS, said the company is proud to enroll the first patient in the brigatinib clinical trial, “as it demonstrates our leadership role in bringing exciting new therapies to cancer patients.”

“We are committed to leading the way in the fight against cancer while providing our patients access to the world’s most advanced cancer treatments and cutting-edge clinical trials,” Choquette said.

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