Table 5.
Overall summary of AEs (safety population as of July 7, 2023)
| AE (n, %) | Dostarlimab + chemotherapy (N = 121) | Pembrolizumab + chemotherapy (N = 122) |
|---|---|---|
| AEs | 119 (98) | 119 (98) |
| TRAEs | 103 (85) | 99 (81) |
| Dostarlimab or pembrolizumab-related AEs | 86 (71) | 70 (57) |
| Grade ≥3 AEs | 78 (64) | 78 (64) |
| Grade ≥3 TRAEs | 78 (64) | 77 (63) |
| AEs leading to treatment discontinuation | 35 (29) | 46 (38) |
| Dostarlimab or pembrolizumab-related AEs leading to treatment discontinuation | 20 (17) | 29 (24) |
| SAEs | 50 (41) | 58 (48) |
| Dostarlimab or pembrolizumab-related SAEs | 14 (12) | 17 (14) |
| Fatal AEsa | 15 (12) | 12 (10) |
| Fatal TRAEb | 3 (2) | 5 (4) |
| Immune-mediated lung disease | 1 (<1) | 0 |
| Myelosuppression | 0 | 1 (<1) |
| Pneumonia | 0 | 1 (<1) |
| Pneumonitis | 1 (<1) | 0 |
| Septic shock | 0 | 1 (<1) |
| Thrombocytopenia | 0 | 1 (<1) |
| Fatal dostarlimab or pembrolizumab-related AEs | 3 (2)c | 2 (2)d |
| irAEse | 38 (31) | 47 (39) |
| irSAEs | 12 (10) | 11 (9) |
AE adverse event, ir immune-related, SAE serious adverse event, TRAE treatment-related adverse event.
aPatients who had a fatal AE recorded and death was not recorded as due unequivocally to disease under study.
bAEs described as treatment-related could be related to any study treatment agent.
cPneumonitis; immune-related pneumonitis, urosepsis.
dMyelosuppression, respiratory failure.
eNo new immune-related deaths were observed.