Related Experiment Video

Updated: Mar 4, 2026

Monitoring PD-1-Blocking Antibodies Bound to T Cells Derived from a Drop of Peripheral Blood
06:07

Monitoring PD-1-Blocking Antibodies Bound to T Cells Derived from a Drop of Peripheral Blood

Published on: February 5, 2020

6.2K

A pharmacovigilance data-driven approach to reveal high fatal adverse events following checkpoint immunotherapy

Zhen Sun1, Xuan Deng2, Jianglong Guo1

  • 1State Key Laboratory of Systems Medicine for Cancer, Shanghai Cancer Institute, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200032, China.

Proceedings of the National Academy of Sciences of the United States of America
|March 2, 2026
PubMed

Insights

Immune checkpoint inhibitors (ICIs) improve cancer treatment but cause adverse events (AEs). This study identified 63 high-mortality AEs from ICI therapy, like lung disease and liver failure, requiring vigilant monitoring to reduce patient fatality.

Area of Science:

  • Oncology
  • Pharmacovigilance
  • Immunotherapy

Background:

  • Immune checkpoint inhibitors (ICIs) have revolutionized cancer therapy.
  • However, ICIs are associated with a spectrum of treatment-related adverse events (AEs).
  • Identifying high-mortality AEs is crucial for patient safety.

Purpose of the Study:

  • To introduce a modified pharmacovigilance approach to identify "ICI-related high-mortality AEs".
  • To determine the types and prevalence of these severe complications.
  • To inform proactive monitoring and intervention strategies.

Main Methods:

  • Analysis of large-scale pharmacovigilance data from FDA AEs Reporting System (148,972 cases) and WHO VigiBase (142,645 cases).
  • Identification of specific AE types with disproportionately elevated fatality rates during ICI therapy.
  • Corroboration of findings using additional clinical datasets.

Main Results:

  • Identified 63 distinct types of ICI-related high-mortality AEs.
  • Examples include interstitial lung disease, myositis, and hepatic failure.
  • Patients experiencing these AEs had significantly higher fatality rates (36.25%) compared to other AEs (10.66%).

Conclusions:

  • The study successfully identified critical ICI-related high-mortality AEs.
  • These findings highlight the need for heightened clinical vigilance.
  • Proactive monitoring and targeted interventions are essential to mitigate ICI-related mortality risk.
Keywords:
adverse eventcheckpoint immunotherapydrug safetyfatalitypharmacovigilance analysis

More Related Videos

Author Spotlight: Magnetic Fluorescent Bead-Based Dual-Reporter Flow Analysis of PDL1-Vaxx Peptide Vaccine-Induced Antibody Blockade of the PD-1/PD-L1 Interaction10:18

Author Spotlight: Magnetic Fluorescent Bead-Based Dual-Reporter Flow Analysis of PDL1-Vaxx Peptide Vaccine-Induced Antibody Blockade of the PD-1/PD-L1 Interaction

Published on: July 7, 2023

1.8K
Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis07:40

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis

Published on: March 20, 2021

18.6K

Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.9K
Therapeutic Drug Monitoring: Affecting Factors01:29

Therapeutic Drug Monitoring: Affecting Factors

Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
293
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
508
Therapeutic Drug Monitoring: Overview and Classification01:16

Therapeutic Drug Monitoring: Overview and Classification

Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...
445
Therapeutic Drug Monitoring: Drug Analysis Methods01:26

Therapeutic Drug Monitoring: Drug Analysis Methods

Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood or body tissues to tailor drug therapy effectively. This monitoring is critical for managing drugs with narrow therapeutic indices like digoxin and phenytoin, ensuring they are both safe and effective. For instance, monitoring theophylline levels in asthma patients involves precision and sensitivity to adjust doses according to individual responses to therapy, ensuring efficacy and...
251
Pharmacogenomics: Identification of New Drug Targets01:29

Pharmacogenomics: Identification of New Drug Targets

Advances in genomics have profoundly influenced drug discovery by increasing both the speed and accuracy of pharmaceutical development. Pharmacogenomics, which examines how genetic variation influences drug response, facilitates the identification of novel therapeutic targets and enables patient stratification for personalized treatment. These strategies contribute to improved drug efficacy, minimized adverse effects, and more efficient clinical trial design.Mapping genetic differences...
53