Comprehensive Assessment of Cancer Immunotherapy Response

Project SummaryImmune checkpoint inhibitor (ICIs) immunotherapies can result in robust and durable disease control in many advanced malignancies, and their use is transforming cancer care. Despite the growing adoption, however, ICIs are effective in andlt;30% of patients and can cause significant immune-related adverse events (irAEs) in up to ~60% of treated patients. Early determination of which patient will respond and/or develop irAEs remains a great challenge due to the complex interplay of tumor response, toxicity in critical organs, and overall patterns of immune activation. Further complicating their use, ICI costs are high ($100k-$250k annually/patient; total Medicare Part B payment for ICIs in 2018 andgt;$4 billion). A comprehensive assessment of early ICI therapeutic response and toxicity would provide oncologists with timely, actionable information to better balance benefits and risks, improve patient outcomes, reduce toxicities and lower healthcare costs.Molecular imaging is an invaluable tool for assessing spatial and temporal changes in tumors, damage to critical organs and immune activation during immunotherapies. Unfortunately, current assessments require manually evaluating a subset of disease sites, which is both laborious and subjective. Immunotherapies’ unique mechanism of action often gives rise to novel imaging patterns of tumor response (e.g. pseudoprogression) that cannot be easily resolved by current methods. Disease response, organ toxicity, and lymphoid tissue immune activation are interdependent. Information on all three of these aspects of response must be known to capture the complete landscape of immunotherapy response. The status quo in assessing response not only fails to fully extract clinically significant information from the imaging data, but also provides very limited information to medical oncologists for improved overall patient management. To address this unmet need, AIQ Solutions (Madison, WI) proposes to develop ImmunIQ , a software product that provides a comprehensive view of immunotherapy response. Specifically, ImmunIQ will automatically and simultaneously assess: (1) response of all tumor lesions, (2) immune-related toxicities in critical organs, and (3) immune activation. Upon successful completion of Phase I, we will have a functional software prototype. In Phase II, we will clinically validate the platform with outcome and irAE data and develop a prototype ready for commercialization and FDA 510(k) submission.Project Narrative Immune checkpoint inhibitor immunotherapies have been transforming the treatment strategies in many advanced malignancies, however despite the growing adoption, it suffers from significant challenges, including low response rate, high incidence of immune-related adverse events, and high treatment costs. A comprehensive assessment of early immunotherapy response would provide oncologists with timely, actionable information to better balance benefits and risks, improve patient outcomes, reduce toxicities and lower healthcare costs. To meet this need, AIQ Solutions proposes to develop ImmunIQ, a software product that automatically analyzes patients’ molecular images to provide quantitative and simultaneous data on (1) response of all tumor lesions, (2) immune-related toxicities in critical organs, and (3) immune activation.