HealthDay News — Durvalumab results in significantly longer overall survival than placebo among patients with stage 3, unresectable non-small cell lung cancer who did not have disease progression after concurrent chemoradiotherapy, according to a study published September 25 in the New England Journal of Medicine.
Scott J. Antonia, MD, PhD, from the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida, and colleagues randomly assigned patients in a two-to-one ratio to receive durvalumab (n=473) intravenously (10mg per kilogram of body weight) or placebo (n=236) every 2 weeks for up to 12 months.
The researchers found that the 24-month overall survival rate was 66.3% in the durvalumab group versus 55.6% in the placebo group (two-sided P=.005). Overall survival was significantly prolonged with durvalumab versus placebo (stratified hazard ratio [HR] for death, 0.68; P=.0025). For progression-free survival, the median duration was 17.2 months in the durvalumab group and 5.6 months in the placebo group (stratified HR for disease progression or death, 0.51). The median time to death or distant metastasis was 28.3 months in the durvalumab group and 16.2 months in the placebo group (stratified HR, 0.53). Grade 3 or 4 adverse events of any cause occurred in 30.5% of the patients in the durvalumab group and 26.1% in the placebo group. In addition, 15.4% and 9.8% of the patients, respectively, discontinued the trial regimen because of adverse events.
“Adding durvalumab to the standard treatment has made a big impact for this group of patients,” Antonia said in a statement. “It’s allowing them to live longer and potentially increasing their chance for cure.”
Several authors disclosed ties to pharmaceutical companies, including AstraZeneca, which supported the study.