In a nutshell
This study examined the safety and effectiveness of durvalumab (Imfinzi) in patients with stage III non-small cell lung cancer. This study concluded that durvalumab delayed time to disease progression.
Chemotherapy and radiation are the standard treatment options for stage III non-small cell lung cancer (NSCLC, cancer that has spread to the local lymph nodes) that cannot be surgically removed. However, many patients will progress despite these treatments. New options are needed.
Durvalumab is a therapy that targets the PD-1 receptor on cancer cells. Blocking PD-1 leads the immune system to attack the cancer cells. This can lead to cell death. Durvalumab has been shown to be effective in other forms of cancer. It is not clear whether it is effective in patients with stage 3 NSCLC.
Methods & findings
This study examined the safety and effectiveness of durvalumab in NSCLC. 709 patients who had already received chemotherapy and radiotherapy were included. Patients were randomly assigned to treatment with durvalumab or a placebo (substance with no active effect). Patients were followed for an average of 14.5 months.
The average time to disease progression was 16.8 months for those on durvalumab and 5.6 for those on placebo. The percentage of patients without disease progression at 12 months was 55.9% for durvalumab versus 35.3% for placebo. The average time to death or distant (spread) disease was 23.2 months for durvalumab versus 14.6 months for placebo.
Safety in both patient groups was similar, with serious side effects in 29.9% of the durvalumab group and 26.1% in the placebo group. Serious side effects included pneumonia, a type of lung infection.
The bottom line
This study concluded that overall survival and time to disease progression were improved with durvalumab.
The fine print
This is an interim study and therefore overall survival values may change.
Discuss this trial and durvalumab with your doctor.
Published By :
The New England Journal of Medicine
Sep 08, 2017