February 16, 2018—This afternoon, the U.S. Food and Drug Administration (FDA) expanded the approval of durvalumab, a PD-L1 inhibitor, to include the treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC) whose cancer has not progressed following chemotherapy or radiation. Durvalumab has previously been approved for patients with advanced urothelial carcinoma.
“This is the first treatment approved for stage III unresectable non-small cell lung cancer to reduce the risk of the cancer progressing, when the cancer has not worsened after 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 in the press release announcing the approval. “For patients with stage III lung cancer that cannot be removed surgically, the current approach to prevent progression is chemoradiation. 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.”
This approval comes from results from the randomized, multicenter, phase III PACIFIC trial (NCT02125461) published in The New England Journal of Medicine last November. The trial randomized 713 patients whose cancer had not progressed following chemoradiotherapy. Median progression-free survival for patients receiving the checkpoint inhibitor was 16.8 months compared to 5.6 months for patients receiving placebo. Further, the overall response rate for patients receiving durvalumab was 28.4% compared with 16.0% for patients receiving placebo. Grade 3 or 4 adverse events occurred in 29.9% of the patients receiving durvalumab, the most common of which was pneumonia. Other common side effects included cough, fatigue, inflammation of the lungs, upper respiratory tract infections, difficulty breathing, and rashes.
Jonathan A. Bell
Published Online: Friday, February 16, 2018