WCLC 2025 - Posters & ePosters-P3.12.10 Adapting RECIST for Real-World Data: Independent Imaging Read Methodology Over Successive Treatments in a NSCLC Data Registry

Pdf Summary

This study presents an adapted methodology for applying RECIST 1.1 criteria to evaluate tumor response in real-world data (RWD) from a non-small cell lung cancer (NSCLC) registry, specifically focusing on patients with MET exon 14 (METex14) skipping mutations. Traditional large Phase III trials may be unfeasible for small biomarker-defined NSCLC subpopulations; hence, post-authorization real-world cohort studies offer a practical alternative to confirm treatment effectiveness.<br /><br />The approach involves independent imaging reads of CT/MRI scans collected longitudinally across successive treatment lines in the MOMENT registry, a multinational database capturing routine clinical practice data on METex14 NSCLC patients receiving systemic therapy. Images are segmented into lines of treatment, with baseline images identified for each line, enabling re-selection of target lesions for accurate response assessment despite the less structured imaging schedules typical of real-world settings.<br /><br />The review process consists of multiple sessions where two independent radiologists evaluate lesions following adapted RECIST 1.1 criteria, including allowances for reselection of target lesions post-baseline, non-automatic classification of new lesions in previously unscanned areas as progressive disease (PD), and exclusion of brain lesions and fluid collections from progression criteria. A third radiologist adjudicates disagreements to ensure rigor comparable to clinical trial independent review committees.<br /><br />Testing of this methodology on preliminary MOMENT data and subsets of clinical trial data demonstrated feasibility and consistency with conventional clinical trial assessments. This approach could provide unbiased overall response rate estimates in real-world studies and serve as an easier-to-implement alternative to confirmatory Phase III trials for rare lung cancer subgroups and other orphan indications where large randomized trials are challenging.<br /><br />In summary, the study introduces a practical, rigorous imaging read methodology tailored for RWD in NSCLC, facilitating reliable assessment of treatment activity in biomarker-defined patient populations outside traditional trial settings. This method advances post-authorization effectiveness evaluation and may inform regulatory decisions and clinical practice in rare cancer contexts.

Asset Subtitle

S Peter Eggleton

Meta Tag

Speaker S Peter Eggleton

Topic Metastatic Non-small Cell Lung Cancer – Targeted Therapy

Keywords

RECIST 1.1

real-world data

non-small cell lung cancer

MET exon 14 skipping mutation

tumor response evaluation

MOMENT registry

independent imaging review

post-authorization cohort study

treatment effectiveness assessment

biomarker-defined subpopulations