The impact of digital patient monitoring on health outcomes and healthcare resource utilization in patients receiving immunotherapy in clinical practice: Results from an early terminated study.

e13711 Background: Patients with cancer who receive immunotherapy experience symptoms that, if not managed promptly, can negatively impact quality of life (QoL) and clinical outcomes. Remote or digital patient monitoring (DPM) tools may improve health outcomes versus usual care by enabling patients to report symptoms between clinic visits and access educational materials and self-management instructions. However, more evidence is needed to enhance DPM integration in the clinic. ORIGAMA was an interventional study that assessed the clinical value of DPM in patients receiving immunotherapy (ClinicalTrials.gov: NCT05694013). The sponsor terminated the study early owing to a portfolio review, not because of new efficacy data, new or unexpected safety risks, or quality reasons. Here, we present the data collected before study termination. Methods: Patients with metastatic non-small cell lung cancer, extensive-stage small-cell lung cancer or advanced/unresectable hepatocellular carcinoma were randomized 1:1 to an approved intravenous atezolizumab regimen and standard-of-care support with or without DPM.Outcome measures included the MD Anderson Symptom Inventory (MDASI) symptom interference and severity scores, and QoL measures. Unplanned hospital visits and adverse events (AEs) were also recorded. Results: At study termination, 49 patients with a mean age of 65.1 years had enrolled (DPM group, n=24; control group, n=25). Baseline characteristics were similar in the groups, although 72.0% of patients in the control group were >64 years old versus 45.8% in the DPM group. Median (interquartile range) atezolizumab exposure was 1.87 (0.03–4.63) months in the control group and 4.19 (2.51–6.28) months in the DPM group. MDASI completion rates were ≥78.6% during treatment. MDASI symptom interference and severity scores were numerically lower in the DPM group than in the control group at most time points; differences were not deemed clinically important. Numerical improvements from baseline were observed in the DPM group at weeks 18 and 24 in the European Organization for Research and Treatment of Cancer Global Health Status score; no differences between groups were observed in the 5-level EuroQol-5D visual analogue scale. In the DPM group, 12 patients were hospitalized versus 7 in the control group; the median hospitalization duration was 4 days in the DPM group and 11 days in the control group. The safety profile of atezolizumab was consistent with previous reports; no new safety concerns were identified. No adverse device effects, serious or nonserious, were reported during the study. Conclusions: Conclusions regarding the clinical value of DPM are precluded by the small sample size; however, these data may inform the design of future studies assessing the impact of DPM on health outcomes and healthcare resource use. Clinical trial information: NCT05694013 .