Table 3.
Treatment-related Adverse Events (≥ Grade 3).
| KEYNOTE-177 | CheckMate 142 | |||
|---|---|---|---|---|
| Treatment line | 1st | ≥ 2nd | ≥ 2nd | |
| Number of patients | 153 | 154 | 74 | 119 |
| Regimen | Pembro | Chemo | Nivo | Nivo + Ipi* |
| Any TRAE | 22% | 66% | 20% | 32% |
| Diarrhea | 2% | 10% | 1% | 2% |
| Fatigue | 2% | 9% | 1% | 2% |
| Nausea | 0% | 2% | 0% | 1% |
| Stomatitis | 0% | 4% | 1% | 1% |
| Neutropenia | 0% | 15% | - | - |
| Hepatitis | 3% | 0% | 1% | 11% |
| Colitis | 3% | 0% | 1% | - |
| Hypothyroidism | 0% | 0% | 0% | 1% |
| Hyperthyroidism | 0% | 0% | 0% | 0% |
| Endocrine | 1% | 0% | 1% | 5% |
| Skin | 1% | 1% | 1% | 4% |
| Pulmonary | 0% | 0% | 0% | 1% |
Abbreviations: Pembro, pembrolizumab; Nivo, nivolumab; Ipi, ipilimumab; Chemo, chemotherapy;
* Nivo 3 mg/kg + Ipi 1 mg/kg every 3 weeks (four doses), followed by Nivo 3 mg/kg biweekly