Prospective, non-interventional, multisite evaluations of TRAQinform Immuno algorithmic quantitative treatment response analysis on treatment intent decisions in metastatic melanoma.

9529 Background: Molecular imaging plays a critical role in assessing immunotherapy response in metastatic melanoma, but current assessment methods may not fully leverage imaging data to inform clinical decision-making. This study prospectively evaluated whether integrating TRAQinform Immuno quantitative analysis into clinical assessment would alter oncologists' treatment intent in metastatic melanoma patients receiving checkpoint inhibitor combinations. Methods: In this prospective, multisite, non-interventional study (NCT05819255), patients with metastatic melanoma receiving dual-agent immunotherapy were enrolled at the University of Wisconsin Carbone Cancer Center and Massachusetts General Hospital Cancer Center. FDG PET/CT scans were acquired at baseline, 3-4 weeks and 12 weeks. All scans were analyzed using a research version of the TRAQinform IQ (TRAQinform) algorithmic quantitative software. At each timepoint, treating oncology and nuclear medicine teams recorded treatment intent before and after review of the TRAQinform analysis report. A cross-site, blinded review was conducted to assess potential status quo bias. Results: Twenty-six patients were enrolled (12F, 14M, mean age 65 years), 25 of whom completed all study scans. At week 3-4, 27% of cases (7/26) showed an intent to change treatment after oncologists reviewed the TRAQinform report, (p=1.0). At the 12-week assessment, 56% of cases (14/25) demonstrated intent to change treatment (p=0.0008). Considering either timepoint, 65% of cases (17/26) exhibited a change in treatment intent compared to baseline (p=0.000006). Cross-site analysis indicated minimal influence of status quo bias on intent decisions. Conclusions: In this prospective study assessing intent to treat, TRAQinform analysis of standard-of-care FDG PET/CT images influenced oncologists treatment decision in the majority of metastatic melanoma patients, suggesting it provides clinically actionable information. For oncologists managing patients on dual-agent immunotherapy - where treatment decisions often involve uncertainty and clinical judgment, this study demonstrates that TRAQinform offers an additional data-driven tool to support optimal therapeutic decision-making. Research reported in this abstract was supported by the National Cancer Institute of the National Institutes of Health and under Award Number R44CA257253. The content is solely the responsibility of the authors and does not necessarily represent the official news of the National Institutes of Health. Clinical trial information: NCT05819255 .