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Durvalumab after chemoradiotherapy in stage III NSCLC: 4-year survival update from the phase III PACIFIC trial
Faivre-Finn, Corinne Vicente, D. Kurata, T. Planchard, D. Paz-Ares, L. Vansteenkiste, J. F. Spigel, D. R. Garassino, M. C. Reck, M. Senan, S.
Faivre-Finn, Corinne
Vicente, D.
Kurata, T.
Planchard, D.
Paz-Ares, L.
Vansteenkiste, J. F.
Spigel, D. R.
Garassino, M. C.
Reck, M.
Senan, S.
Citations
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Abstract
Background: In the phase III PACIFIC trial of patients (pts) with unresectable Stage III
NSCLC without disease progression after concurrent chemoradiotherapy (cCRT),
durvalumab significantly improved progression-free survival (PFS; stratified HR 0.52,
95% CI 0.42e0.65; P<0.0001; median 16.8 vs 5.6 months; data cutoff [DCO], 13 Feb
2017) and overall survival (OS; stratified HR 0.68, 95% CI 0.53e0.87; P¼0.0025;
median not reached vs 28.7 months; DCO, 22 Mar 2018) vs placebo (pbo), with
manageable safety. We report updated, exploratory analyses of survival outcomes at
4 years, including the first estimate of median OS for the durvalumab arm.
Methods: Pts with WHO PS 0/1 (any tumour PD-L1 status) who had received _2
cycles of platinum-based cCRT (RT dosage typically 60e66 Gy in 30e33 fractions)
were enrolled and randomised (2:1), 1e42 days post-cCRT, to IV durvalumab 10 mg/
kg or pbo (q2w for _12 months), stratified by age, sex, and smoking history. Primary
endpoints were PFS (blinded independent central review; RECIST v1.1) and OS (both
measured from the time of randomisation). HRs and 95% CIs were estimated using a
stratified log-rank test in the ITT population. Medians and OS/PFS rates at 48 months
were estimated by KaplaneMeier method.
Results: In total, 709/713 randomised patients received durvalumab (n/N¼473/476)
and pbo (n/N¼236/237). The last pt had completed study treatment in May 2017,
almost 3 years prior to the current DCO. As of 20 Mar 2020 (current DCO; median
follow up, 34.2 months [range, 0.2e64.9]), updated PFS (stratified HR 0.55, 95% CI
0.44e0.67; median 17.2 vs 5.6 months) and OS (stratified HR 0.71, 95% CI 0.57e0.88)
remained consistent with previous reports. Median OS for the durvalumab arm was
determined for the first time: 47.5 months (pbo, 29.1 months). The 48-month OS
rates were 49.6% vs 36.3% for durvalumab vs pbo, and PFS rates were 35.3% vs 19.5%
respectively. Updates to treatment effects for pt subgroups will be reported.
Conclusions: These updated analyses of PFS and OS demonstrate durable benefit with
durvalumab after cCRT. Approximately half of patients randomised to durvalumab in
PACIFIC remain alive at 4 years, and about a third remain both alive and progression
free, almost 3 years after the last pt completed study treatment.
Description
Date
2020
Publisher
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Keywords
Type
Meetings and Proceedings
Citation
Faivre-Finn C, Vicente D, Kurata T, Planchard D, Paz-Ares L, Vansteenkiste JF, et al. LBA49 Durvalumab after chemoradiotherapy in stage III NSCLC: 4-year survival update from the phase III PACIFIC trial. Annals of Oncology. 2020;31:S1178-S9.