Authors : Pallippat Thumban Kheif Mamu; Saira Susan Thomas; Hamlin Joseph Antony; Manjima Sunil

Volume/Issue : Volume 10 - 2025, Issue 11 - November

Google Scholar : https://tinyurl.com/mrxmwntm

Scribd : https://tinyurl.com/3jtw4fbz

DOI : https://doi.org/10.38124/ijisrt/25nov1424

Note : A published paper may take 4-5 working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and ResearchGate.

Abstract : PD-1/PD-L1 inhibitors have reshaped modern oncology by restoring antitumor T-cell activity and producing durable clinical responses across diverse malignancies. Yet, their therapeutic benefits are tempered by a wide and often unpredictable spectrum of immune-related adverse events (irAEs). Real-world data consistently demonstrate a broader and more heterogeneous toxicity profile than that reported in clinical trials, with approximately 43% of treated patients developing irAEs—most commonly endocrine, hepatic, and hematologic. Although many events are manageable, rare but severe toxicities such as myocarditis, cholestatic liver injury, aseptic meningitis, and neuromuscular syndromes underscore the need for heightened vigilance and rapid intervention. Baseline factors, including age, ECOG performance status, and comorbidities, significantly influence irAE risk and may explain higher toxicity rates in real-world populations. Rechallenge after an irAE remains challenging, with recurrence rates of 28–32% and contraindications in serious cardiac or neurologic toxicities. Real-world datasets provide important advantages by capturing diverse patient groups, identifying rare or delayed toxicities, and reflecting heterogeneous clinical practice. Nonetheless, limitations such as under-reporting, inconsistent case definitions, and lack of denominator data restrict precise incidence estimation. Future priorities include standardized multicentre registries, biomarker-guided risk stratification, and AI-assisted monitoring to improve early detection and management. Overall, real-world evidence is essential for defining the full safety profile of PD-1/PD-L1 inhibitors and guiding safer, individualized immunotherapy.

Keywords : PD-1 Inhibitors, Immune Checkpoint Inhibitors, Immune-Related Adverse Events (irAEs), Real-World Evidence (RWE), Real-World Toxicity, Pharmacovigilance, Post-Marketing Surveillance, Safety Profile, Toxicity Patterns.

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