PURPOSEThe 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; P =.00251) and progression-free survival (PFS [blinded independent central review; RECIST v1.1]; stratified HR, 0.52; 95% CI, 0.42 to 0.65; P <.0001), with manageable safety. We report updated, exploratory analyses of survival, approximately 5 years after the last patient was randomly assigned.METHODSPatients 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.RESULTSSeven 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 v 29.1 months) and PFS (stratified HR, 0.55; 95% CI, 0.45 to 0.68; median, 16.9 v 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.CONCLUSIONThese 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.
|Number of pages||11|
|Journal||Journal of Clinical Oncology|
|Publication status||Published - 2022 Apr 20|
Bibliographical noteFunding Information:
This study ( NCT02125461 ) was sponsored by AstraZeneca. Medical writing support, under the direction of the authors, was provided by Aaron Korpal, PhD, of Ashfield MedComms (Manchester, United Kingdom), an Ashfield Health company, and was funded by AstraZeneca. Jolyon Faria of AstraZeneca (Cambridge, United Kingdom) carried out the technical modeling for the analyses of prognostic factors for survival. C.F.-F. is supported by a grant from the National Institute for Health Research Manchester Biomedical Research Centre. A.R. is supported, in part, by a grant from the National Institutes of Health/National Cancer Institute Cancer Center (support Grant No.: P30 CA008748).
© 2020 American Society of Clinical Oncology.
All Science Journal Classification (ASJC) codes
- Cancer Research