VALO2 non-small cell lung cancer (NSCLC) pilot study

Summary

Background: Metastatic non-small cell lung cancer is a serious disease with high mortality. In recent years, immune checkpoint inhibitors (ICIs) have become an important treatment option for patients whose tumours have high PD-L1 expression. However, information on how these treatments perform in routine clinical practice remains limited.

Objectives: VALO2 aimed to improve understanding of treatment outcomes among patients receiving first‑line immunotherapy for metastatic lung cancer in routine Nordic healthcare. The study also evaluated whether health data from different Nordic countries can be analysed using a common research approach without transferring patient-level data between institutions.

Methods: VALO2 was a multicentre observational study conducted using electronic health record data from Rigshospitalet (Denmark), Helsinki University Hospital (Finland), and Oslo University Hospital (Norway). Data remained within each participating institution and were analysed through secure local environments. Researchers accessed and analysed harmonised Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM)-formatted data remotely, while only aggregated study results were exported for reporting. Compared with the previous VALO1 pilot, VALO2 demonstrated that cross-border research can be conducted through direct analytical access to data within participating Secure Processing Environments (SPEs), while maintaining local data custody.

Results: The final study population included 887 patients from Denmark, 91 patients from Finland, and 76 patients from Norway. In the Danish cohort, the pembrolizumab policy-period group was associated with longer overall survival and more favourable treatment-related outcomes than the atezolizumab policy-period group. In the Finnish cohort, no statistically significant differences were observed between pembrolizumab and cemiplimab. In the Norwegian cohort, patients receiving pembrolizumab had longer overall survival than those receiving cemiplimab. However, this finding should be interpreted with caution because the cemiplimab group was small and the available information for adjustment was limited.

The study also showed that important prognostic factors could be evaluated when sufficient data were available. However, the availability of clinical variables differed between participating sites, demonstrating the continuing challenges of conducting comparable analyses across countries. The participating hospitals successfully implemented a common analytical framework, showing that real-world studies can be performed across national borders without transferring patient-level data between institutions.

Conclusions: VALO2 demonstrated that cross-border real-world data research is feasible using harmonised health data mapped to the OMOP Common Data Model, and local SPEs across Nordic healthcare institutions. The study provided new information on treatment outcomes among the patients receiving first-line immunotherapy in routine clinical practice while highlighting the importance of data availability, cohort implementation and reporting requirements when comparing results across countries. The experience gained through VALO2 supports further development of Nordic federated research infrastructure and demonstrates how secure cross-border access to health data can enable future multinational research while maintaining local control of sensitive patient information.