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Retrospective analysis of clinical trial safety data for pembrolizumab reveals the effect of co-occurring infections on immune-related adverse events
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Retrospective analysis of clinical trial safety data for pembrolizumab reveals the effect of co-occurring infections on immune-related adverse events
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Retrospective analysis of clinical trial safety data for pembrolizumab reveals the effect of co-occurring infections on immune-related adverse events
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Journal Article
Retrospective analysis of clinical trial safety data for pembrolizumab reveals the effect of co-occurring infections on immune-related adverse events
2022
Overview
Biologics targeting PD-1, PD-L1, and CTLA-4 immune checkpoint proteins have been used in a variety of tumor types including small and non-small cell lung cancers, melanoma, and renal cell carcinoma. Their anti-tumor activity is achieved through amplifying components of the patient’s own immune system to target immune response evading cancer cells. However, this unique mechanism of action causes a range of immune related adverse events, irAEs, that affect multiple physiological systems in the body. These irAEs, depending on severity, often cause suspension or discontinuation of therapy and, in rare cases, may lead to fatal outcomes. In this study we focused on pembrolizumab, a PD-1 inhibitor currently approved for multiple types of cancer. We analyzed over ten thousand adverse event reports from Keynote clinical trials of pembrolizumab for various cancer indications with or without co-occurring infections, and observed a statistically significant 80% increase in the risk of developing an irAE in subjects with infections.
Publisher
Public Library of Science,Public Library of Science (PLoS)
Subject
/ Antibodies, Monoclonal, Humanized - adverse effects
/ Antibodies, Monoclonal, Humanized - therapeutic use
/ Antineoplastic Agents, Immunological - adverse effects
/ Antineoplastic Agents, Immunological - therapeutic use
/ Cancer
/ Complications and side effects
/ Disease
/ Drugs
/ Humans
/ Immune Checkpoint Inhibitors - adverse effects
/ Immune Checkpoint Inhibitors - therapeutic use
/ Medicine and Health Sciences
/ Melanoma
/ Pharmacy
/ Programmed Cell Death 1 Receptor - antagonists & inhibitors
/ Research and Analysis Methods
/ Toxicity
/ Tumors
