Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non–Small-Cell Lung Cancer

Abstract

PURPOSE 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; 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. METHODS 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. RESULTS 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 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. CONCLUSION 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.

Affiliated Institutions

• KU Leuven BE
• Chungbuk National University Hospital KR
• Sarah Cannon US
• Institut de Recherche en Cancérologie de Montpellier FR
• University of Manchester GB
• Fondazione IRCCS Istituto Nazionale dei Tumori IT
• Kanagawa Cancer Center
• Yonsei University KR
• Sidney Kimmel Comprehensive Cancer Center US
• AstraZeneca (United Kingdom) GB
• Amsterdam University Medical Centers NL
• Hospital Universitario 12 De Octubre ES
• Université de Montpellier FR
• Guangdong Provincial People's Hospital CN
• The Christie NHS Foundation Trust GB
• AstraZeneca (Japan) JP
• Hospital Universitario Virgen Macarena ES
• Kanagawa Prefectural Hospital Organization JP
• University of Chicago US
• Kansai Medical University JP
• Inserm FR
• Institut Gustave Roussy FR
• Vivantes Klinikum DE
• Bloomberg (United States) US
• Moffitt Cancer Center US
• Tennessee Oncology US
• Guangdong Academy of Medical Sciences CN
• Vrije Universiteit Amsterdam NL
• Westmead Hospital AU
• The University of Sydney AU
• Istanbul University-Cerrahpaşa TR
• Memorial Sloan Kettering Cancer Center US
• German Center for Lung Research DE

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