Patients with non-small cell lung cancer survive longer when their therapy includes durvalumab following platinum-based chemoradiotherapy, reports a new study. The findings of the study are published in the New England Journal of Medicine.
Durvalumab (Imfinzi®) is an immune checkpoint inhibitor that received United States Food and Drug Administration (FDA) approval in February as a new standard-of-care option for patients with stage 3 non-small cell lung cancer where surgery is not an option and whose disease has not progressed following platinum-based chemoradiotherapy.
‘An immune checkpoint inhibitor called Durvalumab which got approval from the United States Food and Drug Administration (FDA) as a new standard-of-care option for stage 3 non-small cell lung cancer patients shows improved survival in patients along with platinum-based chemoradiotherapy.’
The therapy, administered intravenously, helps increase T cell activation by blocking a protein called PD-L1 (programmed cell death ligand 1).
Manufactured by AstraZeneca, durvalumab received initial FDA approval in 2017 for locally advanced or metastatic bladder cancer. But Scott Antonia, M.D., Ph.D., chair of the Department of Thoracic Oncology at Moffitt, saw the potential of durvalumab as a treatment option for patients with advanced non-small cell lung cancer.
Working with AstraZeneca, he launched the PACIFIC clinical trial, a randomized, double-blind, placebo-controlled international phase 3 trial that spanned 235 investigative sites in 26 countries and enrolled more than 700 patients.
"Approximately one-third of patients with non-small cell lung cancer have advanced stage 3 disease at the time of diagnosis. Standard treatment has been chemotherapy and radiation, but 85 percent of patients do not respond to the therapy," said Antonia. "Adding durvalumab to the standard treatment has made a big impact for this group of patients. It's allowing them to live longer and potentially increasing their chance for cure."
The new clinical trial data are based on a two-year follow-up of patients participating in the trial. The findings include:
- Progression-free survival was 17.2 months with durvalumab compared to 5.6 months with placebo
- Overall survival rate at two years was 66.3 percent with durvalumab compared to 55.6 percent with placebo
- Of the patients who had a response to durvalumab, 73.5 percent had an ongoing response at 18 months compared with 52.2 percent in the placebo group