FDA Approves Expanded Use of Immunotherapy Treatment for Lung Cancer Patients

February 19, 2018

TAMPA, Fla. – The Food and Drug Administration announced the expanded approval of Imfinzi® (durvalumab), an immunotherapy treatment that is now available as a standard-of-care option for patients with stage III non-small cell lung cancer. Imfinzi is a monoclonal antibody, delivered intravenously, that helps increase T cell activation by blocking PD-L1 (programmed cell death ligand 1).  

The therapy, manufactured by AstraZeneca, received initial FDA approval in 2017 for locally advanced or metastatic bladder cancer.  The expanded use approval stems from a global clinical trial led by Scott J. Antonia, M.D., Ph.D., chair of the Department of Thoracic Oncology at Moffitt Cancer Center.  Antonia saw the potential of Imfinzi as a treatment option for patients with locally advanced, unresectable non-small cell lung cancer who had not responded to traditional treatments. Working with AstraZeneca, he launched the PACIFIC clinical trial, a randomized, double-blind, international clinical trial that spanned over 20 centers and more than 700 patients. 

“Today’s approval for expanded use is a major milestone in immunotherapy and for lung cancer patients worldwide,” said Antonia. “For 20 years we’ve treated stage III, locally advanced, unresectable, non-small cell lung cancer with chemotherapy and radiation, but 85 percent do not respond. By adding Imfinzi to the traditional standard of care, we’ve seen a huge difference in progression-free survival,” he added.

The PACIFIC trial yielded significant findings. As reported in the Nov. 16 issue of The New England Journal of Medicine:

“The median progression-free survival was 16.8 months with durvalumab versus 5.6 months with placebo; the 12-month progression-free survival rate was 55.9% versus 35.3%, and the 18-month progression-free survival rate was 44.2% versus 27.0%. The response rate was higher with durvalumab than with placebo (28.4% vs. 16.0%), and the median duration of response was longer (72.8% versus 46.8% of the patients had an ongoing response at 18 months).” 

AstraZeneca will work with cancer centers across the United States to begin commercial use of Imfinzi for eligible lung cancer patients. To learn more, please visit https://www.imfinzi.com/patient.html.   

Media Availability: Dr. Scott Antonia is available for interview; please contact Kim Polacek, 813-745-7408//Kim.Polacek@Moffitt.org

FDA News Release: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm597217.htm

AstraZeneca News Release: https://www.astrazeneca-us.com/content/az-us/media/press-releases/2018/us-fda-approves-imfinzi-durvalumab-for-unresectable-stage-iii-non-small-cell-lung-cancer-02162018.html

About Moffitt Cancer Center
Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 49 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s excellence in research, clinical trials, prevention and cancer control. Moffitt is listed as one of the top 10 cancer hospitals in the nation and has been listed in U.S. News & World Report as one of the “Best Hospitals” for cancer care since 1999. Moffitt devotes more than 2 million square feet to research and patient care. Moffitt’s expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet® status, its highest distinction. With more than 5,600 team members, Moffitt has an economic impact in the state of $2.1 billion. For more information, call 1-888-MOFFITT (1-888-663-3488), visit MOFFITT.org, and follow the momentum on Facebook, Twitter and YouTube