The FDA has approved an immunotherapy drug for patients with previously-treated advanced squamous non-small cell lung cancer (NSCLC). Nivolumab, used in multiple clinical trials at Yale Cancer Center for metastatic lung cancer and melanoma, is the only FDA-approved monotherapy in 15 years to demonstrate proven superior overall survival compared to standard of care for this type of cancer.
Nivolumab, called Opdivo by manufacturer Bristol-Myers Squibb, is one of several promising PD-1/PD-L1 inhibitors that allow the body’s immune system to recognize and attack the cancer. The drug has been in clinical trials for advanced lung cancer at Yale for five years, said Roy Herbst, MD, PhD, Ensign Professor of Medicine (Medical Oncology) and professor of Pharmacology; and chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven.
“I’ve seen the data, and it’s extraordinary. A forty-one percent increase in overall survival is amazing and something I never would have anticipated, said Herbst, who also leads the thoracic oncology program at Smilow Cancer Hospital. “We need to continue doing these trials and work on the science so we can extend lives even longer.”
The principle of anti-PD1 therapy was discovered in the laboratory of Lieping Chen, MD, PhD, United Technologies Corporation Professor in Cancer Research and professor of Immunobiology, Dermatology and Medicine (Medical Oncology) at Yale School of Medicine; and director of the Cancer Immunology program at Yale Cancer Center. Chen discovered PD-L1 in 1999 at Mayo Clinic.
Lung cancer survivor Maureen O’Grady said she owes her life to Nivolumab and the clinical trial she enrolled in at Smilow Cancer Hospital at Yale-New Haven. In 2010, O’Grady was diagnosed elsewhere with advanced lung cancer that had metastasized to several areas. A friend suggested she seek care at Smilow.
After several types of chemotherapy-based treatment failed to control her cancer, O’Grady opted to enroll in a study using Nivolumab. Within weeks, her tumors shrank and have not progressed in the two and a half years since the study ended. O’Grady’s oncologist, Scott Gettinger, MD, associate professor of Medicine (Medical Oncology), was the principal investigator on the Nivolumab lung cancer trials at Yale.
“This is wonderful news for me and for others stricken with NSCLC. Today, I feel like I'm part of something historic, and that by participating in a clinical trial I have, in a small way, impacted the world,” O’Grady said. “My family and I will be forever grateful.”