Abstract
The FDA approved nivolumab, a PD-1 inhibitor, for patients with metastatic squamous non–small cell lung cancer that returns during or after treatment with platinum-based chemotherapy. The drug was previously approved to treat patients with unresectable or advanced melanoma.
The FDA approved the PD-1 inhibitor nivolumab (Opdivo; Bristol-Myers Squibb) in March for patients whose metastatic squamous non–small cell lung cancer (NSCLC) returns during or after treatment with platinum-based chemotherapy. Nivolumab is the first immunotherapy approved for lung cancer.
In December, the FDA approved nivolumab to treat patients with unresectable or advanced melanoma, and ongoing clinical trials are investigating whether the drug might be effective against other types of cancer.
Nivolumab's approval “greatly opens the door for the use of immunotherapy in lung cancer,” says medical oncologist Julie Brahmer, MD, director of the Thoracic Oncology Program at the Johns Hopkins Kimmel Cancer Center in Baltimore, MD. Brahmer has worked on clinical trials of the drug and has begun to prescribe it for eligible patients.
The approval was based on a randomized phase III trial that involved 272 patients with metastatic squamous NSCLC whose disease had progressed during or after treatment with platinum-based chemotherapy; 135 received nivolumab and 137 received docetaxel, the standard treatment for patients with recurrent NSCLC. The median overall survival for patients treated with nivolumab was 9.2 months, compared with 6 months for those treated with docetaxel. A separate single-arm phase II trial of 117 patients found that 15% experienced partial shrinkage of their tumors within a median time of 3.3 months.
Lung cancer is the leading cause of cancer death in the United States, with an estimated 159,260 deaths in 2014. NSCLC accounts for seven of every eight lung cancer diagnoses, and the 5-year survival for metastatic disease is 4%.
Researchers are now working to identify the patient populations most likely to benefit from nivolumab, says Brahmer. An ongoing phase III trial is investigating the drug as a first-line treatment for stage IV or recurrent PD-L1–positive disease. Other phase I and II trials are investigating nivolumab combined with other treatments, including chemotherapies and experimental agents, for patients with advanced disease.
As researchers' knowledge grows about how the immune system responds to lung cancer, “we can make immune therapy applicable to more patients,” she says.