Table 3.
Adverse Events That Occurred during the Study Period in the 79 Patients Who Received Neoadjuvant Cemiplimab.*
| Adverse Event | Value | |
|---|---|---|
| Any Grade | Grade ≥3 | |
| no. of patients (%) | ||
| Any event | 69 (87) | 14 (18) |
| Serious event | 13 (16) | 10 (13) |
| Event that led to discontinuation of treatment | 1 (1) | 1 (1) |
| Event that led to death | 4 (5) | 4 (5) |
| Event of any grade that occurred in >5% of patients or grade ≥3 event that occurred in ≥1 patient† | ||
| Fatigue | 24 (30) | 1 (1)‡ |
| Diarrhea | 11 (14) | 1 (1)‡ |
| Nausea | 11 (14) | 0 |
| Maculopapular rash | 11 (14) | 0 |
| Constipation | 9 (11) | 0 |
| Pruritus | 8 (10) | 0 |
| Dizziness | 6 (8) | 0 |
| Anemia | 5 (6) | 1 (1)‡ |
| Decreased appetite | 5 (6) | 0 |
| Hypothyroidism | 5 (6) | 0 |
| Rash | 5 (6) | 0 |
| Arthralgia | 4 (5) | 0 |
| Headache | 4 (5) | 0 |
| Hypoesthesia | 4 (5) | 0 |
| Hyponatremia | 3 (4) | 2 (3)‡ |
| Insomnia | 3 (4) | 1 (1)‡ |
| Confusional state | 2 (3) | 2 (3)‡ |
| Myocardial infarction | 2 (3) | 1 (1)§ |
| Acute myocardial infarction | 1 (1) | 1 (1)§ |
| Agitation | 1 (1) | 1 (1)¶ |
| Cellulitis | 1 (1) | 1 (1)‡ |
| Congestive heart failure | 1 (1) | 1 (1)§ |
| Cholelithiasis | 1 (1) | 1 (1)‡ |
| Coronavirus disease 2019 pneumonia | 1 (1) | 1 (1)§ |
| Delusion | 1 (1) | 1 (1)¶ |
| Bullous dermatitis | 1 (1) | 1 (1)‡ |
| Impaired glucose tolerance | 1 (1) | 1 (1)‡ |
| Increased hepatic enzyme | 1 (1) | 1 (1)‡ |
| Immune-mediated hepatitis | 1 (1) | 1 (1)‡ |
| Hypertension | 1 (1) | 1 (1)‡ |
| Procedural hemorrhage | 1 (1) | 1 (1)¶ |
| Pulmonary embolism | 1 (1) | 1 (1)‡ |
Safety was assessed in all patients who received at least one dose of neoadjuvant cemiplimab. 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.
The adverse events of any grade that occurred in more than 5% of patients are listed in descending order of frequency.
Grade 3 adverse events that occurred during the study period were observed in 8 patients (10%) who received neoadjuvant cemiplimab. A patient may have had more than one grade 3 adverse event.
Grade 5 adverse events that occurred during the study period were observed in 4 patients (5%) who received neoadjuvant cemiplimab.
Grade 4 adverse events that occurred during the study period were observed in 2 patients (3%) who received neoadjuvant cemiplimab: agitation and delusion both occurred in the same patient, and procedural hemorrhage occurred in 1 patient. The grade 4 hemorrhage occurred during a rotation-flap procedure 10 days after resection of the primary tumor; the patient had been taking clopidogrel until 3 days before the rotation-flap procedure and aspirin until the day of the procedure.