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

Jhanelle E. Gray, Augusto Villegas, Davey Daniel, David Vicente, Shuji Murakami, Rina Hui, Takayasu Kurata, Alberto Chiappori, Ki Hyeong Lee, Byoung Chul Cho, David Planchard, Luis Paz-Ares, Corinne Faivre-Finn, Johan F. Vansteenkiste, David R. Spigel, Catherine Wadsworth, Maria Taboada, Phillip A. Dennis, Mustafa Özgüroğlu, Scott J. Antonia

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38 Citations (Scopus)

Abstract

Introduction: 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. Methods: 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. Results: 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. Conclusions: 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.

Original languageEnglish
Pages (from-to)288-293
Number of pages6
JournalJournal of Thoracic Oncology
Volume15
Issue number2
DOIs
Publication statusPublished - 2020 Feb

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine

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    Gray, J. E., Villegas, A., Daniel, D., Vicente, D., Murakami, S., Hui, R., Kurata, T., Chiappori, A., Lee, K. H., Cho, B. C., Planchard, D., Paz-Ares, L., Faivre-Finn, C., Vansteenkiste, J. F., Spigel, D. R., Wadsworth, C., Taboada, M., Dennis, P. A., Özgüroğlu, M., & Antonia, S. J. (2020). Three-Year Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC—Update from PACIFIC. Journal of Thoracic Oncology, 15(2), 288-293. https://doi.org/10.1016/j.jtho.2019.10.002