Statement from Lung-MAP Clinical Trial Leadership Regarding FDA Approval of Nivolumab

For Immediate Release

Media Contact: Ryan Hohman, JD, Managing Director, Policy and Public Affairs, Friends of Cancer Research: 202.944.6708 – rhohman@focr.org or Frank DeSanto, Communications Manager, SWOG Cancer Research: 503.348.1710 – desanto@oshu.edu

Statement from Lung-MAP Clinical Trial Leadership Regarding FDA Approval of Nivolumab

On March 4, 2015, the U.S. Food and Drug Administration (FDA) announced that it had approved Opdivo (nivolumab) for the treatment of patients with previously treated metastatic squamous non-small cell lung cancer. Nivolumab is an agent in a class of drugs known as immunotherapies. This is exciting news for patients who may now have one more option in battling this serious disease.

The Lung-MAP drug selection committee recognized the promise of immunotherapies as treatments for lung cancer when it chose an investigational immune therapy from AstraZeneca/MedImmune to be part of the inaugural launch of the trial.

Given the inherent flexibility of the Lung-MAP study design, the study team–led by co-principal investigators Dr. Vali Papadimitrakopoulou, Professor, Department of Thoracic/Head and Neck Medical Oncology, MD Anderson; Dr. David Gandara, Director, Thoracic Oncology Program, UC Davis; and Dr. Roy Herbst, Chief of Medical Oncology, Yale Cancer Center — are implementing appropriately responsive and timely modifications to the current design of the immunotherapy sub-study of Lung-MAP.

The Lung-MAP clinical trial is open and enrolling patients at over 400 sites in 42 states across the country. The trial continues to efficiently test a range of new agents for the benefit of patients with lung cancer.