Three-Year Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC—Update from PACIFIC

• Published in: Journal of thoracic oncology Vol. 15; no. 2; pp. 288 - 293
• Main Authors: Gray, Jhanelle E., Villegas, Augusto, Daniel, Davey, Vicente, David, Murakami, Shuji, Hui, Rina, Kurata, Takayasu, Chiappori, Alberto, Lee, Ki Hyeong, Cho, Byoung Chul, Planchard, David, Paz-Ares, Luis, Faivre-Finn, Corinne, Vansteenkiste, Johan F., Spigel, David R., Wadsworth, Catherine, Taboada, Maria, Dennis, Phillip A., Özgüroğlu, Mustafa, Antonia, Scott J.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.02.2020; Copyright by the International Association for the Study of Lung Cancer
• Subjects: Antibodies, Monoclonal - therapeutic use; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - pathology; Chemoradiotherapy; Durvalumab; Humans; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Neoplasm Staging; NSCLC; Overall survival; PACIFIC; Three-year update; Three-year update; NSCLC; Overall survival; Durvalumab; PACIFIC
• ISSN: 1556-0864; 1556-1380; 1556-1380
• DOI: 10.1016/j.jtho.2019.10.002

In the phase 3 PACIFIC study of patients with unresectable stage III NSCLC without progression after chemoradiotherapy, durvalumab demonstrated significant improvements versus placebo in the primary end points of progression-free survival (hazard ratio [HR] = 0.52, 95% confidence interval [CI]: 0.42–65, p < 0.0001) and overall survival (OS) (HR = 0.68, 95% CI: 0.53–0.87, p = 0.00251), with manageable safety and no detrimental effect on patient-reported outcomes. Here, we report 3-year OS rates for all patients randomized in the PACIFIC study. Patients, stratified by age, sex, and smoking history, were randomized (2:1) to receive durvalumab, 10 mg/kg intravenously every 2 weeks, or placebo for up to 12 months. OS was analyzed by using a stratified log-rank test in the intention-to-treat population. Medians and rates at 12, 24, and 36 months were estimated by the Kaplan-Meier method. As of January 31, 2019, 48.2% of patients had died (44.1% and 56.5% in the durvalumab and placebo groups, respectively). The median duration of follow-up was 33.3 months. The updated OS remained consistent with that previously reported (stratified HR = 0.69 [95% CI: 0.55–0.86]); the median OS was not reached with durvalumab but was 29.1 months with placebo. The 12-, 24- and 36-month OS rates with durvalumab and placebo were 83.1% versus 74.6%, 66.3% versus 55.3%, and 57.0% versus 43.5%, respectively. All secondary outcomes examined showed improvements consistent with previous analyses. Updated OS data from PACIFIC, including 3-year survival rates, demonstrate the long-term clinical benefit with durvalumab after chemoradiotherapy and further establish the PACIFIC regimen as the standard of care in this population.