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

Author:

Spigel David R.1ORCID,Faivre-Finn Corinne2ORCID,Gray Jhanelle E.3,Vicente David4,Planchard David5ORCID,Paz-Ares Luis6ORCID,Vansteenkiste Johan F.7ORCID,Garassino Marina C.89ORCID,Hui Rina10,Quantin Xavier11,Rimner Andreas12ORCID,Wu Yi-Long13ORCID,Özgüroğlu Mustafa14ORCID,Lee Ki H.15ORCID,Kato Terufumi16ORCID,de Wit Maike17,Kurata Takayasu18ORCID,Reck Martin19ORCID,Cho Byoung C.20ORCID,Senan Suresh21ORCID,Naidoo Jarushka22ORCID,Mann Helen23,Newton Michael24ORCID,Thiyagarajah Piruntha23ORCID,Antonia Scott J.3

Affiliation:

1. Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN

2. The University of Manchester and The Christie NHS Foundation Trust, Manchester, United Kingdom

3. H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL

4. Hospital Universitario Virgen Macarena, Seville, Spain

5. Department of Medical Oncology, Thoracic Unit, Gustave Roussy, Villejuif, France

6. Universidad Complutense, CiberOnc, CNIO and Hospital Universitario 12 de Octubre, Madrid, Spain

7. University Hospitals KU Leuven, Leuven, Belgium

8. Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

9. Department of Hematology/Oncology, The University of Chicago, Chicago, IL

10. Westmead Hospital and the University of Sydney, Sydney, New South Wales, Australia

11. Montpellier Cancer Institute (ICM) and Montpellier Cancer Research Institute (IRCM), INSERM U1194, University of Montpellier, Montpellier, France

12. Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY

13. Department of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China

14. Istanbul University—Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey

15. Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea

16. Kanagawa Cancer Center, Yokohama, Japan

17. Vivantes Klinikum Neukölln, Berlin, Germany

18. Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan

19. Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany

20. Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea

21. Department of Radiation Oncology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands

22. Sidney Kimmel Comprehensive Cancer Center and Bloomberg-Kimmel Institute for Cancer Immunotherapy at John Hopkins University, Baltimore, MD

23. AstraZeneca, Cambridge, United Kingdom

24. AstraZeneca, Gaithersburg, MD

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.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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