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. 2020 Oct 3;29:45–54. doi: 10.1016/j.jare.2020.09.006

Table 1.

Cardiotoxicity at time of FDA approval.

Drug Approval Participants Antibody Cancer type Cardiotoxicity - related eventsa
Pembrolizumab 2014 834 patients who had no more than one line of prior systemic therapy and not received ipilimumab Humanized anti-PD-1 IgG4 Melanoma Non-small cell lung carcinoma Squamous cell carcinoma of head and neck Urothelial carcinoma, Head, neck squamous cell cancer Various heart diseases; 0–4%*:
-Myocarditis (0.5%)-Myocardial infarction (2%)-Pericarditis (2%)-Arrhythmia (4%)-Takotsubo syndrome
Nivolumab 2014 142 patients, stratified by BRAF V600 mutation status, 109 patients with BRAF V600 wild–type melanoma Human anti-PD-1 IgG4 Classical Hodgkin lymphoma Melanoma Non-small cell lung cancer Renal cell carcinoma Small cell lung cancer Squamous cell carcinoma of head and neck -Myocarditis(<1%)**-Ventricular arrhythmia (1–10%)-Pericarditis (<1%)
Atezolizumab 2016 Urothelial carcinoma; 310 patients had disease progression during or following a platinum platinum–containing chemotherapy, 32% have PD–L1expression Humanized anti-PDL-1 IgG1 Non-small cell lung cancer, urothelial carcinoma - Myocarditis** (<1%)-Myocardial infarction
Durvalumab 2017 Urothelial carcinoma; 182 patients who progressed on platinum–containing chemotherapy Human anti-PDL-1 IgG1 Non-small cell lung cancer, urothelial carcinoma Myocarditis < 1%
Avelumab 2017 Human anti-PDL-1 IgG1 Urothelial carcinoma, Merkel cell carcinoma Myocarditis < 1%
Cemiplimab 2018 Efficacy reported in 250 patients; Phase II Trial Human anti-PD-1 IgG4 Cutaneous Squamous cell carcinoma Myocarditis
a

Label of Food and Drug Administration FDA.

*

Included in the label of Food and Drug Administration (Keynote-087- Keynote-170- Keynote-006).

**

Included in the label of Food and Drug Administration (CHECKMATE-037-clinical trials of OPDIVO administered as a single agent or in combination with ipilimumab and POPLAR trial of atezolizumab).