3068 Background: Radiomics is an image based approach that allows for characterization and quantification of tumor lesions in cancer patients. Radiomics has been proven capable of potentially adding value in the diagnostic and prognostic patient managment. In this study we evaluated the potential of Radiomics to bring additional insight also in early drug development. Methods: All the visible malignant lung and liver metastasis lesions of 7 uveal melanoma patients (86% of women, 60±11y) treated with IOA-244 (EudraCT 2019-000686-20) were manually segmented and analyzed in their size and shape via a radiomics approach. The CT scans at baseline and first follow-up (8 weeks) were included in the study and compared. Descriptive statistics and linear mixed effect (LME) models were used to quantify volumetric lesion-specific response to treatment. Response has been defined both as continuous variable and in three discrete categories (lesion shrinkage, stable and progressive disease for a volume change of [-100%;-0%];[0%-+25%] and > 25%, respectively). The influence of lesion shape at baseline (e.g. compactness, elongation or surface roughness among others) on the treatment response has been explore through LME models as well. Results: We identified and segmented 126 metastatic lesions (70 lung and 56 liver) from baseline scans and 122 lesions (71 lung and 51 liver) from post treatment scans. Of those, 64% could be consistently mapped between visits, resulting in a total of 147 matching lesions on which the radiomics analysis was performed. We found 19% of complete response and 16% of new lesions appearing. 8 weeks after treatment start, we observed non progressive disease in 61% of all lesions, of which 42% was shrinking. LME did not show a significant change in lesion volume between visits, but the mean difference between visits was negative. LME did show that lesion shape is significantly different between progressors and non-progressors at baseline for lung lesions (compact and irregular lesions are more likely to respond), and that there are moderate correlations (0.4-0.7) between tumor shape and volume change for liver lesions (compact lesions have a larger volume drop). Conclusions: This work demonstrates both the clinical potential of IOA-244 for treatment of Uveal Melanoma patients with lesions in the lung and in the liver and the potential of radiomics individual lesion analysis for clinical research in the very early stages of drug development. Lesion evolution volumetric assessment has allowed a more accurate and sensitive understanding of IOA-244 efficacy and impact across different lesions, in both lung and liver. Radiomics showed a promising response of selected population to IOA-244 over the first time point (W0-W8). A further radiomics analysis on next follow-up scans would allow a radiological proof of treatment-induced changes and long-term patient outcome prediction.
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