Immune-Mediated Adverse Events with Pembrolizumab Administration in the Treatment of Solid Tumors
Keywords:
pembrolizumab; anti-PD-1; immune-mediated events; observational studies.Abstract
Introduction: Pembrolizumab is the most widely used anti-PD-1 antibody in oncology, with a positive impact and a characteristic toxicity profile due to systemic immune activation.
Objective: This review is to synthesize the available observational evidence on the toxicity associated with pembrolizumab use in patients with solid tumors and the characteristics of the studies that document it.
Methods: A systematic review was conducted in PubMed between 2010 and 2025 of articles that demonstrate immune-mediated adverse events with the use of the drug in the treatment of patients with solid tumors. PRISMA for systematic reviews was used to identify and select studies, and their quality was assessed using the Newcastle-Ottawa Scale.
Results: 256 real-world observational studies in oncology were selected, all of high or moderate quality, and most involving patients with lung, melanoma, and head and neck cancers. In the distribution of events, endocrine (27 %), dermatological (23 %), and gastrointestinal (20 %) events predominated, with 70-85 % of these being Grade I-II. The main risk factors were prolonged exposure, concomitant therapies, and comorbidities.
Conclusions: Real-world observational studies using pembrolizumab were predominantly in patients with lung, melanoma, and head and neck cancers, with a higher frequency of non-serious endocrine, dermatological, and gastrointestinal immune-mediated events, regardless of tumor type and therapeutic combination, with documented evidence from high- and moderate-quality studies.
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