TABLE 2.
Summary of Treatment-Related Adverse Events
| Adverse Eventa | Patients, No. (%) | |
|---|---|---|
| Any Grade | Grade 3b | |
| Any event | 10 (83) | 5 (42) |
| Serious event | 5 (42) | 5 (42) |
| Event that led to discontinuation of treatment | 1 (8) | 1 (8) |
| Event that led to death | 0 | 0 |
| Event of any grade that occurred in ≥10% of patients or grade 3-5 events that occurred in 1 or more patients |
||
| Endocrine | ||
| Hyperthyroidism | 2 (17) | — |
| GI disorders | ||
| Diarrhea | 2 (17) | 1 (8)c |
| General disorders | ||
| Limb edema | 3 (25) | — |
| Fatigue | 7 (64) | — |
| Infections and infestations | ||
| Lung infection | 1 (8) | 1 (8)d |
| Skin infection | 1 (8) | 1 (8) |
| Upper respiratory infection | 2 (17) | 1 (8)d |
| Metabolism and nutrition disorders | ||
| Acidosis | 1 (8) | 1 (8) |
| Hyperkalemia | 1 (8) | 1 (8) |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 2 (17) | — |
| Skin and subcutaneous tissue disorders | ||
| Maculopapular rash | 2 (17) | — |
| Vascular disorders | ||
| Hypertension | 2 (17) | — |
| Total events | 25 | 6 |
Abbreviation: mTOR, mammalian target of rapamycin.
Safety was assessed in all patients who received at least one dose of cemiplimab, mTOR inhibitor (sirolimus or everolimus), and prednisone. Treatment-related adverse events were coded according to the preferred terms of the Medical Dictionary for Regulatory Activities, version 24.1. The severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.
No grade 4 or 5 treatment-related events were reported.
Grade 3 immune-related adverse event resulting in diarrhea and dehydration.
Grade 3 adverse events attributed to upper respiratory infection and superimposed COVID-19 pneumonia.