Updated 4-year survival analyses from PACIFIC
De Wit, M. Reck, M.
De Wit, M.
Reck, M.
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Abstract
Background: In the phase 3 PACIFIC trial, durvalumab versus placebo
significantly improved progression-free survival (PFS; stratified HR 0.52,
95% CI 0.42-0.65; P< 0.001; median 16.8 vs 5.6 months; data cutoff [DCO],
13 Feb 2017) and overall survival (OS; stratified HR 0.68, 95% CI 0.53-
0.87; P=0.0025; median not reached vs 28.7 months; DCO, 22 Mar 2018).
Durvalumab exhibited a manageable safety profile and had no detrimental
effect on pt-reported outcomes. These results therefore established the
PACIFIC regimen (durvalumab following concurrent chemoradiotherapy
[cCRT]) as standard of care for pts with unresectable, Stage III NSCLC
and no disease progression after prior cCRT. In addition, OS benefit with
durvalumab was maintained at ~3 years after randomization (stratified
HR 0.69, 95% CI 0.55-0.86; DCO, 31 Jan 2019) and was observed across
most pt subgroups. We will report updated, exploratory subgroup analyses
of 4-year survival (DCO, 20 Mar 2020) and the first update to PFS for
the ITT population since the primary analysis of OS.
Methods: Pts with WHO PS 0/1 (any tumour PD-L1 status) who received
?2 cycles of platinum-based cCRT were randomised (2:1), 1-42 days following
cCRT, to receive durvalumab 10 mg/kg intravenously q2w or placebo,
for up to 12 months, and stratified by age, sex, and smoking history.
Primary endpoints were PFS (blinded independent central review; RECIST
v1.1) and OS. For time-to-event endpoints, treatment effects within
pt subgroups, defined by baseline characteristics and prior treatment, will
be estimated by hazard ratios from unstratified Cox-proportional-hazards
models, with medians and 95% CIs estimated by Kaplan-Meier method.
Expected results: Using the latest DCO (20 Mar 2020), ~4 years after the
last pt was randomized, exploratory analyses to characterize outcomes
in subgroups, based on baseline pt and disease characteristics and prior
treatment, will be presented. In addition, updated results for PFS and OS,
including 48-month survival rates, will be presented for the ITT population.
Expected Conclusions: The updated subgroup analyses from the PACIFIC
trial will provide further insight into long-term survival benefit with
durvalumab after cCRT, including the durability of PFS.
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Date
2020
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Meetings and Proceedings
Citation
De Wit M, Faivre-Finn C, Reck M. Updated 4-year survival analyses from PACIFIC. Oncology Research and Treatment. 2020;43(SUPPL 4):147-