Abstract
51 Background: Treatments for advanced/metastatic (adv/met) GC/GEJC after failure of second-line (2L) chemo are limited. Nivolumab (NIVO) demonstrated encouraging anti-tumor activity and long-term OS in adv/met GC/GEJC Asian patients (pts) in ATTRACTION-2 compared with placebo (12-month OS rate, 26% vs 11%; HR, 0.63; P < .0001) and in CHECKMATE-032 (CM-032) in Western pts (12-months OS rate, 45%). This study explored outcomes in US GC/GEJC pts by establishing real world (RW) standard of care (SOC) comparators, against placebo in Asian pts and NIVO in Western pts. Methods: Data were captured from FH electronic health record database. Median OS, estimated by Kaplan-Meier, was calculated from last treatment for adv/met GC/GEJC to death. To create a US RW SOC arm to the ATTRACTION-2 placebo pts, a 2-step matching process was applied: (1) similar inclusion/exclusion (I/E) criteria (2) frequency matching based on significant differences in baseline characteristics associated with survival, identified by univariate analysis. A similar approach was used to create a US RW SOC arm to NIVO treated pts in CM-032. Results: 742 adv/met GC/GEJC pts with ≥ 2 prior lines of therapy were identified in FH from Jan11-Apr17. Two-step matching resulted in 90 US RW SOC vs. 163 ATTRACTION-2 placebo pts, and 100 US RW SOC vs. 42 CM-032 pts. All pts had ECOG performance status (PS) of 0 or 1. Median OS of US RW SOC arm was similar to matched placebo in ATTRACTION-2. Comparison of RW SOC to NIVO-treated pts in CM-032 showed a favorable median OS with NIVO therapy (Table). Conclusions: These analyses highlight the grave outcomes in US adv/met GC/GEJC pts in FH and signal a need for more effective treatments. The data also suggest favorable outcomes with NIVO vs. SOC in both Asian and Western pts with 3L adv/met GC/GEJC. [Table: see text]
Published Version
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