In February 2018, the FDA approved Imfinzi (durvalumab; from AstraZeneca), a PD-L1 inhibitor, for the treatment of patients with stage III non–small-cell lung cancer (NSCLC) that cannot be removed by surgery (unresectable) and did not progress after chemoradiation.
“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.
“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.
In clinical trials, patients who received Imfinzi had an average of 16.8 months without cancer progression versus 5.6 months with placebo. The average duration of survival without disease progression was 16.8 months with Imfinzi versus 5.6 months with placebo.
The common side effects associated with Imfinzi in patients with unresectable stage III NSCLC include cough, fatigue, pneumonitis, upper respiratory tract infections, dyspnea, and rash.