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Spigel, David R; Faivre-Finn, Corinne; Gray, Jhanelle E; Vicente, David; Planchard, David; Paz-Ares, Luis; Vansteenkiste, Johan F; Garassino, Marina C; Hui, Rina; Quantin, Xavier; Rimner, Andreas; Wu, Yi-Long; Özgüroğlu, Mustafa; Lee, Ki H; Kato, Terufumi; de Wit, Maike; Kurata, Takayasu; Reck, Martin; Cho, Byoung C; Senan, Suresh; Naidoo, Jarushka; Mann, Helen; Newton, Michael; Thiyagarajah, Piruntha; Antonia, Scott J
Journal of clinical oncology, 04/2022, Volume: 40, Issue: 12Journal Article
The phase III PACIFIC trial compared durvalumab with placebo in patients with unresectable, stage III non-small-cell lung cancer and no disease progression after concurrent chemoradiotherapy. Consolidation durvalumab was associated with significant improvements in the primary end points of overall survival (OS; stratified hazard ratio HR, 0.68; 95% CI, 0.53 to 0.87; = .00251) and progression-free survival (PFS blinded independent central review; RECIST v1.1; stratified HR, 0.52; 95% CI, 0.42 to 0.65; < .0001), with manageable safety. We report updated, exploratory analyses of survival, approximately 5 years after the last patient was randomly assigned. Patients with WHO performance status 0 or 1 (any tumor programmed cell death-ligand 1 status) were randomly assigned (2:1) to durvalumab (10 mg/kg intravenously; administered once every 2 weeks for 12 months) or placebo, stratified by age, sex, and smoking history. Time-to-event end point analyses were performed using stratified log-rank tests. Medians and landmark survival rates were estimated using the Kaplan-Meier method. Seven hundred and nine of 713 randomly assigned patients received durvalumab (473 of 476) or placebo (236 of 237). As of January 11, 2021 (median follow-up, 34.2 months all patients; 61.6 months censored patients), updated OS (stratified HR, 0.72; 95% CI, 0.59 to 0.89; median, 47.5 29.1 months) and PFS (stratified HR, 0.55; 95% CI, 0.45 to 0.68; median, 16.9 5.6 months) remained consistent with the primary analyses. Estimated 5-year rates (95% CI) for durvalumab and placebo were 42.9% (38.2 to 47.4) versus 33.4% (27.3 to 39.6) for OS and 33.1% (28.0 to 38.2) versus 19.0% (13.6 to 25.2) for PFS. These updated analyses demonstrate robust and sustained OS and durable PFS benefit with durvalumab after chemoradiotherapy. An estimated 42.9% of patients randomly assigned to durvalumab remain alive at 5 years and 33.1% of patients randomly assigned to durvalumab remain alive and free of disease progression, establishing a new benchmark for standard of care in this setting.
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