The FDA has approved a new indication for durvalumab (Imfinzi, AstraZeneca)–– treating patients with unresectable stage III non–small–cell lung cancer (NSCLC) whose cancer has not progressed after treatment with chemoradiation. Durvalumab becomes the first treatment approved to reduce the risk of cancer progression in these patients.
“For patients with stage III lung cancer that cannot be removed surgically, the current approach to prevent progression is chemoradiation,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Although a small number of patients may be cured with the chemoradiation, the cancer may eventually progress. Patients now have an approved therapy that has been shown to keep the cancer from progressing for a longer time after chemoradiation.”
Lung cancer is the leading cause of cancer death in the United States, with an estimated 222,500 new diagnoses and 155,870 deaths in 2017, according to the National Cancer Institute. The most common type of lung cancer, NSCLC occurs when cancer cells form in the tissues of the lung. In stage III NSCLC, tumors have spread to nearby lymph nodes or into other parts of the body near the lungs.
Durvalumab targets the programmed death 1/programmed death ligand 1 (PD-1/PD-L1) pathway. By blocking these interactions, durvalumab may help the body’s immune system attack cancer cells. Durvalumab was previously granted accelerated approval in 2017 for the treatment of certain patients with locally advanced or metastatic bladder cancer.
The latest approval was based on a randomized trial of 713 patients whose cancer had not progressed after completing chemotherapy and radiation. The trial measured the length of time the tumors did not have significant growth after starting treatment with durvalumab or a placebo (progression-free survival). The median progression-free survival for patients taking durvalumab was 16.8 months compared with 5.6 months for patients receiving a placebo. In addition, AstraZeneca has agreed to a post-marketing commitment to provide additional information from its study to the FDA about how long patients lived following treatment with durvalumab after chemotherapy and radiation (overall survival).
Common side effects of durvalumab in patients with stage III unresectable NSCLC include cough, fatigue, pneumonitis/radiation pneumonitis, upper respiratory tract infections, dyspnea, and rash.
Serious risks of durvalumab include immune-mediated side effects, where the body’s immune system attacks healthy cells or organs, such as the lungs (pneumonitis), liver (hepatitis), colon (colitis), hormone-producing glands (endocrinopathies), and kidneys (nephritis). Other serious side effects of durvalumab include infection and infusion-related reactions. Durvalumab can cause harm to a developing fetus; women should be advised of the potential risk to the fetus and to use effective contraception.
The FDA granted this application priority review and breakthrough therapy designations.
Source: FDA; February 16, 2018.