Association of immune-related adverse events, inflammatory biomarkers, and clinical outcomes in patients treated with ICIs for advanced renal cell carcinoma.

4556 Background: Immune Checkpoint Inhibitors (ICIs) have been the mainstay treatment for advanced renal cell carcinoma (aRCC). However, irAEs are still a challenge in clinical practice. We tested irAEs with inflammatory biomarkers and their association with clinical outcomes. Methods: A retrospective analysis was conducted on adult patients with aRCC treated with ICIs at Emory Winship Cancer Institute between 2018 and 2023. irAEs determined by the primary oncologist and reported by CTCAE v5.0. Univariate and multivariate analyses were conducted to determine the association between race, gender, OS, PFS, clinical benefit (CB, stable disease, partial response, complete response), modified Glasgow Prognostic Score (mGPS), neutrophil to lymphocyte ratio (NLR), monocyte to lymphocyte ratio (MLR), platelet to lymphocyte ratio (PLR), neutrophil to eosinophil ratio (NER), and any grade irAE. MVA was built by controlling gender, race, smoking status, and prior treatment. Results: We analyzed 401 patients; 191 (47.6%) patients experienced any grade irAEs, with 41 (21.5%) of those classified as grade 3 or higher. Of 401 patients, 139 (34.6%) were treated with PD-1 inhibitor (PD-1i) monotherapy, 131 (32.6%) with PD-1i and CTLA-4 inhibitor combination, 108 (26.9%) with PD-1i and tyrosine kinase inhibitor combination. The median follow-up time was 43.0 months (36.5-51.3). On univariate analysis, the incidence of irAEs was higher in females than males (Odds ratio (OR),1.66 (1.08-2.57), p=0.021), White patients had a higher incidence of irAEs compared to African American patients (OR 2.20 (1.32-3.66), p=0.009). On multivariate analysis, low mGPS was correlated with a higher risk of irAEs (OR for mGPS of 0-1-2 was 6.03 (2.07-17.62), 3.75 (1.31-10.70), and reference respectively; p=0.004). irAEs were correlated with greater CB (OR 2.56 (1.53-4.29); p <.001), longer OS (HR 0.55 (0.37-0.82); p=0.003), and longer PFS (HR 0.51 (0.37-0.71); p <.001). Conclusions: Female patients, White patients, and patients with low inflammatory biomarkers may have a higher likelihood of experiencing irAEs. Patients who experienced irAEs may have better outcomes. Future prospective trials are needed for further evidence. Table: see text