Imfinzi First Treatment Approved to Reduce Disease Progression in Unresectable Stage III NSCLC After Chemoradiation

March 2018, Vol 8, No 3 - FDA Approvals, News & Updates


On February 16, 2018, the FDA approved an expanded indication for durvalumab (Imfinzi; AstraZeneca), a PD-L1 inhibitor, for the treatment of patients with unresectable stage III non–small-cell lung cancer (NSCLC) that did not progress after chemoradiation. Durvalumab received accelerated approval in 2017 for the treatment of certain patients with metastatic or locally advanced bladder cancer.

“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. 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.

“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,” Dr Pazdur added.

This new indication for durvalu­mab was based on data from a clinical trial comprising 713 patients with NSCLC that did not progress postchemoradiation. Patients were randomized to receive durvalumab or placebo. The median progression-free survival was 16.8 months with durvalumab versus 5.6 months with placebo. The overall survival rates are still pending, and will be provided to the FDA postmarketing by the sponsor.

The common side effects associated with durvalumab in patients with unresectable stage III NSCLC include cough, fatigue, pneumonitis, upper respiratory tract infections, dyspnea, and rash. Serious side effects include pneumonitis, hepatitis, colitis, endocrinopathies, and nephritis, as well as infection and infusion-related reactions.