Incidence, spectrum, and clinical outcomes of immune-related adverse events in 227 consecutive patients treated with immune checkpoint inhibitors: An Indian real-world cohort.

Abstract

e23392 Background: Real-world safety data on immune checkpoint inhibitors (ICIs) from low- and middle-income countries remain limited. We evaluated the incidence, spectrum, severity, and clinical outcomes of immune-related adverse events (irAEs) in routine oncology practice in India. Methods: This single-centre observational study included 227 consecutive patients treated with PD-1, PD-L1, or CTLA-4 inhibitors between May 2024 and November 2025. irAEs were graded using CTCAE v5.0. Categorical variables were summarized as frequencies and percentages. irAEs were managed per established immunotherapy toxicity guidelines. Results: Among 227 patients, 60 (26.4%) developed ≥1 irAE, accounting for 68 total events; 8 patients experienced multiple events. Grade ≥3 irAEs occurred in 12 events (17.6%). Six Grade ≥3 events led to permanent discontinuation, affecting 4 patients (1.8%). One treatment-related death (0.4%) occurred due to myocarditis. Conclusions: In this real-world cohort, irAEs were predominantly endocrine and dermatologic and were generally manageable. Severe events were uncommon, with low rates of permanent discontinuation and mortality. Organ-system distribution and severity of immune-related adverse events (N=68 events). Organ system Events n (%) ≥ Grade 3 (n) Endocrine 36 (52.9%) 3 Dermatological 18 (26.5%) 3 Hepatic 4 (5.9%) 2 Lung 5 (7.4%) 2 Neurological 1 (1.5%) 1 Cardiac 1 (1.5%) 1 Others 3 (4.4%) 0 *Includes colitis (n=1), uveitis (n=1), and transfusion reaction (n=1).