Moffitt Cancer Center Clinical Trials Help Lead to FDA Approval of New Lung Cancer Immunotherapy

March 30, 2015

TAMPA, Fla. – Clinical trials held at Moffitt Cancer Center have helped lead to the Food and Drug Administration approval of Opdivo (nivolumab), the first and only immunotherapy for patients with advanced non-small cell lung cancer.

Lung cancer is the leading cause of cancer death in the United States. Non-small cell lung cancer affects seven out of eight lung cancer patients. The most common type of lung cancer, non-small cell lung cancer occurs when cancer forms in the cells of the lung.

Opdivo shuts down the PD-1 pathway. PD-1 is a protein that inhibits the body’s immune system from attacking cancerous cells. The immunotherapy is approved for patients with metastatic squamous non-small cell lung cancer with progressed disease on or after being treated with platinum-based chemotherapy.

The March 4 FDA approval was a result of two clinical trials, CheckMate -017 and CheckMate -063. CheckMate -017, a phase III, open-label, randomized, multinational and multicenter study, evaluated Opdivo versus docataxel, which has been the standard of care for NSCLC patients. Results showed that patients receiving Opdivo had a median overall survival of 9.2 months, compared to 6 months for those treated with docataxel. The CheckMate -063 trial studied the side effects of Opdivo, which include fatigue, nausea and loss of appetite.

“The results from these trials and subsequent FDA approval are promising because it shows that immuno-oncology drugs can be effective for difficult-to-treat cancers, such as NSCLC,” said Scott J. Antonia, M.D., Ph.D., chair of the Department of Thoracic Oncology at Moffitt. “Immunotherapy differs from chemotherapy and radiation because it uses the body’s own immune system to target and kill cancer cells, resulting in fewer side effects or quality of life disruptions for patients.”

Opdivo is marketed by Bristol-Myers Squibb.

About Moffitt Cancer Center
Located in Tampa, Moffitt is one of only 41 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s excellence in research, its contributions to clinical trials, prevention and cancer control. Moffitt is the top-ranked cancer hospital in the Southeast and has been listed in U.S. News & World Report as one of the “Best Hospitals” for cancer care since 1999. With more than 4,500 employees, Moffitt has an economic impact in Florida of nearly $1.6 billion. For more information, visit, and follow the Moffitt momentum on FacebookTwitter and YouTube.