MONDAY, Oct. 29, 2018 — Durvalumab results in significantly longer overall survival than placebo among patients with stage III, unresectable non-small cell lung cancer who did not have disease progression after concurrent chemoradiotherapy, according to a study published Sept. 25 in the New England Journal of Medicine.
Scott J. Antonia, M.D., Ph.D., 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 (10 mg per kilogram of body weight) or placebo (n = 236) every two weeks for up to 12 months.
The researchers found that the 24-month overall survival rate was 66.3 percent in the durvalumab group versus 55.6 percent in the placebo group (two-sided P = 0.005). Overall survival was significantly prolonged with durvalumab versus placebo (stratified hazard ratio [HR] for death, 0.68; P = 0.0025). 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 percent of the patients in the durvalumab group and 26.1 percent in the placebo group. In addition, 15.4 percent and 9.8 percent 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.
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Posted: October 2018