Table 3.
Adverse events that occurred during the trial period.
| Variable | Matched 1 | Matched 2 | Matched 3 | Matched 4 | ||||
|---|---|---|---|---|---|---|---|---|
| anti–PD-L1 | anti–PD-1 | anti–PD-L1 | anti–PD-1 | anti–PD-L1 | anti–PD-1 | anti–PD-L1 | anti–PD-1 | |
| Objective response | ||||||||
| No. objective response (n/N) | 62/462 | 57/270 | 45/310 | 56/270 | 34/191 | 19/78 | 8/44 | 7/27 |
| ORR (%) | 13 (11–17) | 21 (16–27) | 15 (11–19) | 21 (16–26) | 18 (13–24) | 24 (15–35) | 18 (8–33) | 26 (11–46) |
| DCR n (%) | 154 (33) | 104 (39) | 104 (34) | 112 (42) | 70 (37) | 41 (53) | 23 (52) | 11 (41) |
| CR n (%) | 16 (3) | 25 (9) | 15 (5) | 18 (7) | 7 (4) | 5 (6) | 5 (11) | 3 (1) |
| PR n (%) | 46 (10) | 32 (12) | 30 (10) | 38 (14) | 27 (14) | 14 (18) | 3 (7) | 4 (2) |
| SD n (%) | 92 (20) | 47 (17) | 59 (19) | 56 (21) | 36 (19) | 22 (28) | 15 (34) | 4 (2) |
| PD n (%) | 240 (52) | 131 (49) | 159 (51) | 111 (41) | 88 (46) | 30 (38) | 15 (34) | 14 (52) |
| Median duration of response | 21.7 (13.0–21.7) | NE (1.6–30.0) | NE (2.0–13.7) | 20.3 (11.5-31.3) | NE (0.9-19.9) | 9.4 (5.7–12.5) | NE (3-NE) | 10 (4–22) |
| Adverse events | ||||||||
| Treatment-related AEs | 319 (69) | 165 (62) | 215 (69) | 187 (69) | 116 (61) | 63 (81) | 29 (66) | 20 (61) |
| Treatment-related AEs (3–5 grade) | 91 (20) | 44 (17) | 50 (16) | 67 (25) | 13 (7) | 17 (22) | 3 (7) | 5 (15) |
| Treatment-related serious AEs | 72 (16) | 32 (12) | 34 (11) | NA | 9 (5) | 8 (10) | 2 (5) | 3 (9) |
| Treatment-related AEs leading to treatment discontinuation | 16 (3) | 18 (7) | 11 (4) | 27 (10) | 9 (5) | 2 (3) | 4 (9) | 2 (6) |
| Treatment-related AEs lead to death | 4 (1) | 4 (2) | 0 | 3 (1) | 2 (1) | 1 (1) | 0 | 0 |
| AEs with incidence ≥1% | ||||||||
| Asthenia | 51 (43) | 17 (5) | 21 (8) | 19 (6) | 0 | 0 | 5 (11) | 0 |
| Circulatory | 0 | 0 | 8 (3) | 0 | 3 (2) | 0 | 0 | 0 |
| Decreased appetite | 56 (18) | 25 (9) | 36 (13) | 26 (8) | 18 (9) | 0 | 2 (5) | 0 |
| Fatigue | 116 (25) | 37 (14) | 93 (34) | 52 (17) | 37 (19) | 28 (36) | 9 (20) | 6 (18) |
| Pyrexia | 40 (9) | 0 | 28 (10) | 17 (5) | 15 (8) | 0 | 0 | 0 |
| Dermatological | 120 (26) | 84 (32) | 54 (20) | 120 (39) | 33 (17) | 39 (50) | 8 (18) | 2 (6) |
| Endocrine | 53 (45) | 19 (5) | 0 | 46 (15) | 9 (5) | 5 (6) | 4 (9) | 0 |
| Gastrointestinal | 161 (35) | 78 (29) | 87 (32) | 106 (34) | 29 (15) | 11 (14) | 9 (20) | 0 |
| Hematogenous | 29 (15) | 8 (10) | 9 (3) | 30 (10) | 8 (4) | 27 (35) | 10 (23) | 1 (3) |
| Hepatic | 0 | 0 | 10 (4) | 15 (5) | 25 (13) | 5 (6) | 3 (7) | 2 (6) |
| Renal | 0 | 0 | 0 | 5 (2) | 1 (1) | 1 (1) | 0 | 0 |
| Respiratory | 35 (11) | 8 (3) | 17 (6) | 14 (5) | 0 | 7 (9) | 1 (2) | 0 |
| Others | 49 (11) | 36 (14) | 0 | 0 | 11 (6) | 10 (13) | 0 | 10 (30) |
(1) Circulatory: atrial fibrillation, cardiorespiratory arrest, hypertension, hypotension, myocarditis (2); dermatological: alopecia, dermatitis acneiform, dry mouth, maculopapular, mucosal inflammation, skin reactions, pruritus, rash, stomatitis, tumor flare, uveitis (3); endocrine:adrenal disorder, diabetes, hypothyroidism, hypophysitis, hyperthyroidism, hypersensitivity, hyperglycemia, pituitary disorder, rheumatoid arthritis, thyroid disorder; (4) gastrointestinal: abdominal pain, colitis, constipation, diarrhea, intestinal perforation, increased amylase, nausea, pancreatitis, vomiting (5); hematogenous: anemia, blood alkaline phosphatase increased, creatine phosphokinase, dehydration, hyponatremia, increased blood ALP level, Infusion-related reaction, leukocyte count decreased, lipase elevated, lymphocyte count decreased, neutropenia, thrombocytopenia (6); hepatic: alanine aminotransferase increased, amylase increased, aspartate aminotransferase increased, blood bilirubin increased, hepatitis (7); renal: nephritis, renal failure, urinary tract obstruction (8); respiratory: cough, dyspnea, interstitial lung disease, pneumonitis, respiratory tract infection, respiratory failure, wheezing (9); others: arthralgia, dysgeusia, edema peripheral, muscle spasms, myalgia, myositis, neuromyopathy, pain, paresthesia, peripheral sensory neuropathy, peripheral sensory neuropathy, rhabdomyolysis, toxic encephalopathy.