Table 3.
Treatment-Related Adverse Event, n (%) |
Navarixin 30 mg + Pembrolizumab 200 mg n = 51 |
Navarixin 100 mg + Pembrolizumab 200 mg n = 54 |
||
---|---|---|---|---|
Any grade | 37 (73) | 33 (61) | ||
Grade 3−5 | 13 (25) | 12 (22) | ||
Led to discontinuation of study drug(s) | 3 (6) | 4 (7) | ||
Led to death | 1 (2) | 0 |
Any Grade | Grade 3–5 | Any Grade | Grade 3–5 | |
---|---|---|---|---|
Most common (≥2 patients in either treatment arm)a | ||||
Neutrophil count decreased | 7 (14) | 5 (10) | 9 (17) | 4 (7) |
Neutropenia | 5 (10) | 1 (2) | 9 (17) | 6 (11) |
Fatigue | 7 (14) | 0 | 5 (9) | 0 |
Pruritus | 6 (12) | 0 | 6 (11) | 0 |
Cough | 3 (6) | 1 (2) | 3 (6) | 0 |
White blood cell count decreased | 3 (6) | 1 (2) | 3 (6) | 1 (2) |
Pyrexia | 2 (4) | 0 | 3 (6) | 0 |
Hypothyroidism | 2 (4) | 0 | 2 (4) | 0 |
Nausea | 1 (2) | 0 | 3 (6) | 0 |
Vomiting | 1 (2) | 0 | 3 (6) | 0 |
Decreased appetite | 3 (6) | 1 (2) | 0 | 0 |
Hyperthyroidism | 2 (4) | 0 | 1 (2) | 0 |
Rash maculo-papular | 2 (4) | 0 | 1 (2) | 0 |
Chills | 0 | 0 | 2 (4) | 0 |
Diarrhea | 0 | 0 | 2 (4) | 0 |
Rash | 0 | 0 | 2 (4) | 0 |
aAmong treatment-related adverse events of any grade, pneumonitis was reported in 1 patient in each treatment arm and colitis was reported in 1 patient in the navarixin 30-mg arm; neutropenic fever was not reported as a treatment-related adverse event in either treatment arm