Real-World Evidence of Atezolizumab in Unresectable Recurrent NSCLC: Insights From Japan's Next-Generation Medical Infrastructure Act
Author(s)
Yosuke Nishida, BSc1, Suguru Nozue, M.S.1, Shinsuke Kurosu, MPharm2, Fuminori Ohba, PhD2, Yukinori Sakata, MPharm, RPh3, Mie Kasai Azuma, PhD, RPh3, Rika Abe, RPh4, Rika Okamoto, PhD5, Yuki Nakagami, PhD, Graduate Certificate in Biostatistics6, Yasushi Okuno, PhD7, Masahiko Nakatsui, Ph.D.8.
1NTT DATA Corporation, Tokyo, Japan, 2EA Pharma Co.,Ltd, Tokyo, Japan, 3Eisai Co., Ltd, Tokyo, Japan, 4RIKEN Center for Computational Science, Tokyo, Japan, 5Translational Research Centre for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, Kobe, Japan, 6Faculty of Data Science, Shimonoseki City University, Shimonoseki, Japan, 7Graduate School of Medicine, Kyoto University, Kyoto, Japan, 8Graduate School of Medicine, Yamaguchi University, Ube, Japan.
1NTT DATA Corporation, Tokyo, Japan, 2EA Pharma Co.,Ltd, Tokyo, Japan, 3Eisai Co., Ltd, Tokyo, Japan, 4RIKEN Center for Computational Science, Tokyo, Japan, 5Translational Research Centre for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, Kobe, Japan, 6Faculty of Data Science, Shimonoseki City University, Shimonoseki, Japan, 7Graduate School of Medicine, Kyoto University, Kyoto, Japan, 8Graduate School of Medicine, Yamaguchi University, Ube, Japan.
OBJECTIVES: To demonstrate the potential of rapidly generating domestic clinical data for evidence-based drug selection in real-world settings. Specifically, to assess the effectiveness of atezolizumab in patients with unresectable, advanced recurrent NSCLC using RWD from electronic medical records collected under Japan's Next-Generation Medical Infrastructure Act. Additionally, to compare the effectiveness with the results of the Japanese subgroup analysis of the OAK trial.
METHODS: Data from 75 NSCLC patients treated with atezolizumab were extracted from the Millennium Medical Record database. Key metrics included progression-free survival (PFS) and overall survival (OS). PFS was defined as the time from treatment initiation to disease progression or death, based on RECIST v1.1 , and OS was defined as the time from treatment initiation to death. These metrics were analyzed using the Kaplan-Meier method and subgroup analyses based on ECOG-PS and disease stage. The effectiveness evaluation was conducted by performing morphological analysis on the text information from electronic medical records, listing expressions related to RECIST v1.1(CR, PR, SD, PD), and assessing PFS. Mortality was evaluated based on in-hospital deaths from DPC data, and a chart review of the electronic medical records was conducted.
RESULTS: The median PFS was 3.5 months (95% CI: 2.3-8.9 months). Subgroup analyses indicated a correlation between poorer ECOG-PS, advanced stage, and reduced PFS. The median OS was not reached, and the 1-year survival rate was 83.0%.
CONCLUSIONS: This observational study demonstrates the potential of using electronic medical records to generate Real World Evidence on effectiveness of atezolizumab in NSCLC, the OS evaluation faced challenges due to censoring from patient transfers and the difficulty in assessing post-transfer mortality. Linking with National Data Base (NDB) and death certificates may improve post-transfer mortality assessment. Future improvements in data linkage and follow-up are anticipated to enhance survival analysis accuracy.
METHODS: Data from 75 NSCLC patients treated with atezolizumab were extracted from the Millennium Medical Record database. Key metrics included progression-free survival (PFS) and overall survival (OS). PFS was defined as the time from treatment initiation to disease progression or death, based on RECIST v1.1 , and OS was defined as the time from treatment initiation to death. These metrics were analyzed using the Kaplan-Meier method and subgroup analyses based on ECOG-PS and disease stage. The effectiveness evaluation was conducted by performing morphological analysis on the text information from electronic medical records, listing expressions related to RECIST v1.1(CR, PR, SD, PD), and assessing PFS. Mortality was evaluated based on in-hospital deaths from DPC data, and a chart review of the electronic medical records was conducted.
RESULTS: The median PFS was 3.5 months (95% CI: 2.3-8.9 months). Subgroup analyses indicated a correlation between poorer ECOG-PS, advanced stage, and reduced PFS. The median OS was not reached, and the 1-year survival rate was 83.0%.
CONCLUSIONS: This observational study demonstrates the potential of using electronic medical records to generate Real World Evidence on effectiveness of atezolizumab in NSCLC, the OS evaluation faced challenges due to censoring from patient transfers and the difficulty in assessing post-transfer mortality. Linking with National Data Base (NDB) and death certificates may improve post-transfer mortality assessment. Future improvements in data linkage and follow-up are anticipated to enhance survival analysis accuracy.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD155
Topic
Real World Data & Information Systems
Topic Subcategory
Health & Insurance Records Systems
Disease
Biologics & Biosimilars, Oncology