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 |
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).