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Updated: Dec 28, 2025
Identifying PD-1/PD-L1 Inhibitors with Surface Plasmon Resonance Technology
Published on: May 2, 2025
Fatal adverse events associated with programmed cell death protein 1 or programmed cell death-ligand 1 monotherapy in
Bin Zhao1, Hong Zhao2, Jiaxin Zhao3
1Second Affiliated Hospital and Yuying Children's Hospital, Wenzhou Medical University, 109 Xueyuan West Rd, Wenzhou, 325035, China.
Background:
The introduction of antibodies targeting programmed cell death protein 1 (PD-1) and programmed cell death-ligand 1 (PD-L1) into clinical practice has had a revolutionary effect on cancer treatment. However, the incidence and risk of fatal adverse events (FAEs) following PD-1/PD-L1 inhibitor administration are controversial.
Methods:
We performed a systematic search for randomized controlled trials (RCTs) of PD-1/PD-L1 inhibitors (atezolizumab, avelumab, durvalumab, nivolumab, and pembrolizumab) in Embase, PubMed, the Cochrane database, and abstracts presented at American Society of Clinical Oncology and European Society of Medical Oncology from inception to July 2018. FAEs were extracted from each study and pooled to calculate overall incidence and odds ratios (ORs).
Results:
In total, 20 RCTs involving 12,398 patients with solid tumors were included in this study. The overall incidence of FAEs with PD-1/PD-L1 inhibitors was 0.43% [95% confidence interval (CI), 0.25-0.66%]. However, the incidences of FAEs varied significantly by tumor type and median follow-up time. Compared with conventional agents, the application of PD-1/PD-L1 inhibitors significantly reduced the risk of FAEs (OR, 0.56; 95% CI, 0.35-0.89; p = 0.015). Moreover, trial sequential analysis confirmed that our results were solid and reliable; further studies were unlikely to alter this conclusion. FAEs occurred dispersed in major organ systems, with the most common mortalities appearing in the respiratory system (46.2%).
Conclusions:
Compared with conventional treatment, PD-1/PD-L1 blockade monotherapy is associated with a significantly reduced risk of mortality in patients with solid tumors.
Insights
Immune checkpoint inhibitors targeting PD-1/PD-L1 reduce mortality risk in solid tumors. Fatal adverse events (FAEs) were less frequent with these therapies compared to conventional treatments.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Trials
Background:
- Programmed cell death protein 1 (PD-1) and programmed cell death-ligand 1 (PD-L1) inhibitors have revolutionized cancer treatment.
- The safety profile, specifically fatal adverse events (FAEs), associated with these immune checkpoint inhibitors requires further clarification.
Purpose of the Study:
- To systematically evaluate the incidence and risk of FAEs associated with PD-1/PD-L1 inhibitors in patients with solid tumors.
- To compare the risk of FAEs between PD-1/PD-L1 inhibitors and conventional treatments.
Main Methods:
- A systematic literature search was conducted across major databases (Embase, PubMed, Cochrane) and conference abstracts up to July 2018.
- Randomized controlled trials (RCTs) involving PD-1/PD-L1 inhibitors (atezolizumab, avelumab, durvalumab, nivolumab, pembrolizumab) were included.
- Data on FAEs were extracted and pooled to calculate incidence and odds ratios (ORs).
Main Results:
- Twenty RCTs with 12,398 patients were analyzed. The overall incidence of FAEs was 0.43%.
- PD-1/PD-L1 inhibitors significantly reduced the risk of FAEs compared to conventional agents (OR, 0.56; p=0.015).
- Trial sequential analysis confirmed the robustness of these findings. Respiratory system events were the most common cause of mortality (46.2%).
Conclusions:
- PD-1/PD-L1 blockade monotherapy is associated with a significantly lower risk of mortality compared to conventional treatments in solid tumor patients.
- The findings suggest a favorable safety profile regarding mortality for these immunotherapies.
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