Apricityrx Companion Digital Therapeutic For Evidence-Based Mitigation And Phenotype-Linked Molecular Characterization Of Iraes In Patients Receiving Immune Checkpoint Therapy (Ict).

TPS2089 Background: Presentation of immune-related adverse events (irAEs) is heterogeneous and unpredictable in patients receiving immune checkpoint therapy (ICT). ICT has been approved for cancer patients as single agent, combination of dual ICT, ICT plus chemotherapy, and ICT plus targeted therapy. Given the ever increasing complexity in recognizing and managing irAEs, coupled with the lack of skilled resources and clinical experience in real world practice, there is increasing demand for digital solutions that can detect early toxicity and support evidence-based interventions in real world practice. To this end, we have developed ApricityRx, a companion digital therapeutic for end-to-end irAE management. In addition to (i) teaching patients about immune-related toxicities and (ii) empowering them to monitor key symptoms and vital signs, ApricityRx continuously analyzes the combined patient-reported data and longitudinal EMR data to (iii) detect symptom-triggers and lab test-triggers of irAEs, and (iv) activate the clinical team to triage, evaluate and treat in a timely fashion, while (v) providing access to synthesized longitudinal patient information and expert guidance on evidence-based management and care. In a feasibility trial conducted in a community setting, we demonstrated two-thirds of the study participants completed on average 5 eCheck-ins per calendar week (overall average 4 times per week), with 5% of the check-ins resulting in notifications alerting the clinical team to evaluate for the early signs of an irAE. Methods: To accelerate translational research in irAEs and to develop predictive biomarkers for risk stratification, we are launching a single-arm, open-label study that utilizes ApricityRx in patients receiving ICT alone or in combination. The objectives of the study will include (i) defining the operative characteristics of ApricityRx as an irAE mitigation strategy; (ii) identifying patients and time points for phenotype-triggered biospecimen collection and molecular characterization. The study aims to enroll initially up to 100 participants per site, with a total target of 1,000.