Table 2. Adverse Events in All Treated Patients in the PD-L1 CPS of 1 or Greater Population.
| Event, No. (%) | All grade | Grade 3-5 | All grade | Grade 3-5 | All grade | Grade 3-5 |
|---|---|---|---|---|---|---|
| Pembrolizumab (n = 254) | Pembrolizumab + chemotherapy (n = 250) | Chemotherapy (n = 244) | ||||
| Any | 242 (95.3) | NA | 244 (97.6) | NA | 240 (98.4) | NA |
| Drug-related | 138 (54.3) | NA | 235 (94.0) | NA | 224 (91.8) | NA |
| Grade 3-5 | NA | 43 (16.9) | NA | 183 (73.2) | NA | 169 (69.3) |
| Led to discontinuation | 10 (3.9) | NA | 69 (27.6) | NA | 44 (18.0) | NA |
| Led to deatha | 3 (1.1) | NA | 5 (2.0) | NA | 3 (1.2) | NA |
| Drug-related events in ≥5% of patients in either group | ||||||
| Nausea | 9 (3.5) | 1 (0.4) | 145 (58.0) | 19 (7.6) | 120 (49.2) | 18 (7.4) |
| Fatigue | 25 (9.8) | 1 (0.4) | 90 (36.0) | 19 (7.6) | 63 (25.8) | 14 (5.7) |
| Anemia | 13 (5.1) | 4 (1.6) | 90 (36.0) | 30 (12.0) | 80 (32.8) | 35 (14.3) |
| Neutropenia | 0 | 0 | 88 (35.2) | 63 (25.2) | 95 (38.9) | 68 (27.9) |
| Decreased appetite | 19 (7.5) | 3 (1.2) | 75 (30.0) | 11 (4.4) | 74 (30.3) | 17 (7.0) |
| Vomiting | 9 (3.5) | 0 | 66 (26.4) | 12 (4.8) | 71 (29.1) | 14 (5.7) |
| Diarrhea | 16 (6.3) | 3 (1.2) | 63 (25.2) | 12 (4.8) | 62 (25.4) | 14 (5.7) |
| PPE syndrome | 0 | 0 | 59 (23.6) | 12 (4.8) | 44 (18.0) | 8 (3.3) |
| Neutrophil count decreased | 2 (0.8) | 2 (0.8) | 56 (22.4) | 34 (13.6) | 37 (15.2) | 22 (9.0) |
| Mucosal inflammation | 2 (0.8) | 0 | 41 (16.4) | 11 (4.4) | 34 (13.9) | 15 (6.1) |
| Peripheral sensory neuropathy | 1 (0.4) | 0 | 32 (12.8) | 3 (1.2) | 15 (6.1) | 0 |
| Stomatitis | 4 (1.6) | 0 | 31 (12.4) | 11 (4.4) | 34 (13.9) | 9 (3.7) |
| White blood cell count decreased | 2 (0.8) | 0 | 30 (12.0) | 7 (2.8) | 24 (9.8) | 10 (4.1) |
| Rash | 16 (6.3) | 0 | 27 (10.8) | 1 (0.4) | 10 (4.1) | 0 |
| Thrombocytopenia | 0 | 0 | 27 (10.8) | 7 (2.8) | 24 (9.8) | 6 (2.5) |
| Hypothyroidism | 19 (7.5) | 1 (0.4) | 26 (10.4) | 1 (0.4) | 7 (2.9) | 0 |
| Asthenia | 7 (2.8) | 1 (0.4) | 26 (10.4) | 9 (3.6) | 39 (16.0) | 10 (4.1) |
| Neuropathy peripheral | 0 | 0 | 26 (10.4) | 4 (1.6) | 15 (6.1) | 2 (0.8) |
| Blood creatinine increased | 2 (0.8) | 1 (0.4) | 25 (10.0) | 0 | 31 (12.7) | 1 (0.4) |
| Hypomagnesemia | 1 (0.4) | 0 | 24 (9.6) | 8 (3.2) | 22 (9.0) | 8 (3.3) |
| Constipation | 4 (1.6) | 0 | 23 (9.2) | 0 | 26 (10.7) | 0 |
| Platelet count decreased | 2 (0.8) | 0 | 23 (9.2) | 8 (3.2) | 16 (6.6) | 2 (0.8) |
| Weight decreased | 2 (0.8) | 0 | 23 (9.2) | 2 (0.8) | 15 (6.1) | 1 (0.4) |
| Dysgeusia | 2 (0.8) | 0 | 22 (8.8) | 0 | 26 (10.7) | 0 |
| Leukopenia | 0 | 0 | 21 (8.4) | 6 (2.4) | 24 (9.8) | 1 (0.4) |
| Pruritus | 20 (7.9) | 0 | 18 (7.2) | 0 | 8 (3.3) | 0 |
| Alopecia | 0 | 0 | 17 (6.8) | 0 | 11 (4.5) | 0 |
| Tinnitus | 0 | 0 | 16 (6.4) | 0 | 18 (7.4) | 1 (0.4) |
| Hypokalemia | 0 | 0 | 16 (6.4) | 4 (1.6) | 20 (8.2) | 10 (4.1) |
| Dry skin | 3 (1.2) | 0 | 12 (4.8) | 0 | 10 (4.1) | 0 |
| Dizziness | 2 (0.8) | 0 | 12 (4.8) | 1 (0.4) | 9 (3.7) | 1 (0.4) |
| Dehydration | 1 (0.4) | 0 | 12 (4.8) | 7 (2.8) | 16 (6.6) | 6 (2.5) |
| Skin hyperpigmentation | 0 | 0 | 12 (4.8) | 0 | 6 (2.5) | 0 |
Abbreviations: CPS, combined positive score; NA, not applicable; PD-L1, programmed cell death ligand 1; PPE, palmar-plantar erythrodysesthesia.
a
Grade 5 drug-related events were pneumonitis, malignant neoplasm progression, and pericardial effusion in 1 patient each in the pembrolizumab group; febrile neutropenia, myocardial ischemia, colitis, sepsis, and malignant progression in 1 patient each in the pembrolizumab plus chemotherapy group; and multiple organ failure, pneumonitis, and pulmonary embolism in 1 patient each in the chemotherapy group.