- Durvalumab, a new immunotherapy agent, improves progression-free survival in patients with locally advanced, unresectable stage III non-small-cell lung cancer according to the PACIFIC phase 3 trial.
- Durvalumab, an inhibitor of programmed death-ligand 1, could be considered now as a first-line therapy for patients with programmed death-ligand 1 expression.
Why this matters
- Standard treatment gives a progression-free survival of about 8 months and only 15% of patients are alive at 5 years.
- Immunotherapy decreases the probability of disease progression by 48%.
- It is the first innovative treatment for these patients since more than 10 years.
- PACIFIC enrolled 709 patients who had not progressed after platinum-based chemotherapy and radiation therapy.
- Patients had a WHO performance status 0/1 and any programmed death-ligand status were selected from the larger sample enrolled in the PACIFIC study and randomly assigned 2:1 to durvalumab (n=473) and placebo (n=236).
- Co-primary endpoints were progression-free survival and overall survival.
- Median follow-up was 14.5 months.
- Funding: AstraZeneca.
- The median progression-free survival was 16.8 months in the durvalumab arm compared with 5.6 months with placebo.
- Objective response rate was higher (28.4% versus 16.0%) and median duration of response was longer (not reached versus 13.8 months) with durvalumab.
- Median time to death or to distant metastasis was 23.2 months versus 14.6 months with placebo.
- Adverse events occurred in 68% of patients in durvalumab group compared with 53% in the placebo group.
- Overall survival rates are not yet available and will be analysed after a longer follow-up.
- Patients with programmed death-ligand 1 expression are a small minority of the patients with non-resectable advanced non-small-cell lung cancer.