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P3.12.32 Long-Term Survival Outcome After First-Li ...
P3.12.32 Long-Term Survival Outcome After First-Line Osimertinib Monotherapy in Advanced/Metastatic NSCLC: Results From LC-SCRUM-Asia
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This study analyzed long-term overall survival (OS) following first-line (1L) osimertinib monotherapy in Japanese patients with advanced/metastatic common EGFR-mutated (a/m cEGFRm) non-small cell lung cancer (NSCLC), using real-world data from the LC-SCRUM-Asia registry. Osimertinib was approved in Japan in 2018, with prior clinical trials (FLAURA) reporting a median OS of 38.6 months and survival rates at 2 and 3 years of 74% and 54%, respectively. However, real-world evidence in Japan has been limited by small sample sizes and short follow-up.<br /><br />The study included 809 patients treated with 1L osimertinib between August 2018 and March 2022, with follow-up until December 2024. Median patient age was 71 years; 65% were female; 95% had stage IV disease; and common metastases included brain (31%), bone (40%), and liver (11%). Nearly half (48%) had EGFR L858R mutations, and 52% had exon 19 deletions. Most patients (86%) exhibited at least one risk factor linked to poorer survival, such as older age (≥75 years), brain/liver/bone metastases, or L858R mutations.<br /><br />Key findings included a median real-world OS of 35.2 months (95% CI: 31.6–38.1), which was approximately 3.4 months shorter than in the FLAURA trial. Real-world survival rates were 86% at 1 year, 66% at 2 years, and 49% at 3 years—lower by 8% and 5% at 2 and 3 years, respectively, compared to clinical trial data. A real-world best overall response rate of 65% was observed. Multivariate analysis showed that age ≥75, brain, liver, bone metastases, and L858R mutation were significantly associated with higher mortality risk.<br /><br />Notably, 26% of patients did not receive second-line (2L) therapy after discontinuing 1L osimertinib. Among those who received 2L treatment (57%), chemotherapy (37%) and tyrosine kinase inhibitors (23%) were the most common.<br /><br />This real-world study highlights that Japanese patients with a/m cEGFRm NSCLC experience shorter overall survival with 1L osimertinib compared to clinical trial outcomes, underscoring the need for improved first-line treatment strategies in this population. Limitations include potential selection bias inherent in registry-based observational studies.
Asset Subtitle
Hiroki Izumi
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Speaker
Hiroki Izumi
Topic
Metastatic Non-small Cell Lung Cancer – Targeted Therapy
Keywords
osimertinib
non-small cell lung cancer
EGFR mutation
overall survival
real-world data
Japanese patients
first-line therapy
metastasis
tyrosine kinase inhibitors
LC-SCRUM-Asia registry
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