Table 2.
Overview of adverse events from Keynote 629, Carskin and EMPOWER trial.
| EMPOWER – CSCC 1 (25–27) | KEYNOTE 629 (31) | CARSKIN (32) | |||
|---|---|---|---|---|---|
| Group1* | Group2* | Group3* | |||
| Drug | Cemiplimab | Pembrolizumab | Pembrolizumab | ||
| Dose | 3 mg/kg q2W mCSCC | 3 mg/kg q2W laCSCC | 350 mg q3W | 200 mg q3W | 200 mg q3W |
| Any TRAE | 58% | 78% | 64% | 67% | 71% |
| TRAE grade ≥3 | 19% | 10% | 13% | 6% | 7% |
| Treatment-related death | 0 | 1 pt (aspiration pneumonia) | 0 | 1 pt (cranial nerve neuropathy) | 1 pt |
| TRAE-led discontinuation | 8% | 8% | 10% | 12% | na |
| Most frequent TRAE | Fatigue (27%) | Fatigue (28%) | Rash (13%) | Pruritus (14%) | Fatigue (18%) |
| 1st | |||||
| 2nd | Arthralgia (8%) | Pruritus (22%) | Fatigue (11%) | Asthenia (13%) | Diarrhea (13%) |
| 3rd | Diarrhea (8%) | Diarrhea (17%) | Hypothyroidism (11%) | Fatigue (12%) | Hypothyroidism (13%) |
*Group 1, 3 mg/kg once every 2 weeks mCSCC; Group 2, 3 mg/kg once every 2 weeks laCSCC; Group 3, 350 mg once every 3 weeks.
CSCC, cutaneous squamous cell carcinoma; laCSCC, local advanced CSCC; mCSCC metastatic CSCC; TRAE, treatment related adverse events.