Three-year overall survival update from the PACIFIC trial
de Wit, M. Gray, J. E. Villegas, A. Daniel, D. Vicente, D. Murakami, S. Hui, R. Kurata, T. Chiappori, A. Lee, K. H.
de Wit, M.
Gray, J. E.
Villegas, A.
Daniel, D.
Vicente, D.
Murakami, S.
Hui, R.
Kurata, T.
Chiappori, A.
Lee, K. H.
Citations
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Abstract
Background: In the PACIFIC study of patients with unresectable, St. III
NSCLC without progression after chemoradiotherapy (CRT), durvalumab
demonstrated significant improvements versus placebo in the primary
endpoints of progression-free survival (HR, 0.52; 95% CI, 0.42-65; P<
0.0001) and overall survival (HR, 0.68; 95% CI, 0.53-0.87; P=0.00251).
Safety was similar and durvalumab had no detrimental effect on patient-
reported outcomes. Here, we report 3-year OS rates for all patients
randomized in the PACIFIC study.
Methods: Patients with WHO PS 0/1 who received ?2 cycles of platinum-
based CRT were randomized (2:1), 1-42 days following CRT, to receive
durvalumab 10 mg/kg i.v. every 2 weeks or placebo, up to 12 months,
and stratified by age, sex, and smoking history. OS was analyzed using a
stratified log-rank test in the ITT population. Medians and OS rates at 12,
24 and 36 months were estimated by Kaplan-Meier method.
Results: In total, 713 patients were randomized of whom 709 received
treatment (durvalumab, n=473; placebo, n=236). The last patient had
completed the protocol-defined 12 months of study treatment in May
2017. As of Jan 31, 2019 (data cutoff), 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 (range, 0.2-51.3). Updated
OS remained consistent with that previously reported (stratified HR
0.69, 95% CI, 0.55-0.86), with the median not reached (NR; 95% CI, 38.4
months-NR) with durvalumab versus 29.1 months (95% CI, 22.1-35.1)
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. After discontinuation, 43.3% and 57.8% in the durvalumab
and placebo groups, respectively, received subsequent anticancer
therapy (9.7% and 26.6% subsequently received immunotherapy). OS
subgroup results will be presented.
Conclusions: Updated OS data from PACIFIC, including 3-year survival
rates (ITT & PD-L1 ?1% subgroup), underscore the long-term clinical
benefit with durvalumab following CRT and further establish the PACIFIC
regimen as the standard of care in this population.
Description
Date
2019
Publisher
Collections
Keywords
Type
Meetings and Proceedings
Citation
De Wit M, Gray JE, Villegas A, Daniel D, Vicente D, Murakami S, et al. Three-year overall survival update from the PACIFIC trial. Oncology Research and Treatment. 2019;42:76-