TABLE 3.
Summary of treatment‐emergent adverse events (occurring in ≥10% of patients) and grade ≥3 events for original and modified formulations (combination partners pooled) a
| n (%) | Any event | Grade ≥3 event | ||||
|---|---|---|---|---|---|---|
| Total (N = 54) | Original formulation b (N = 15) | Modified formulation b (N = 32) | Total (N = 54) | Original formulation b (N = 15) | Modified formulation b (N = 32) | |
| Any events | 51 (94.4) | 15 (100) | 29 (90.6) | 24 (44.4) | 4 (26.7) | 14 (43.8) |
| Blood and lymphatic system | ||||||
| Anemia | 14 (25.9) | 4 (26.7) | 8 (25.0) | 6 (11.1) | 1 (6.7) | 3 (9.3) |
| Gastrointestinal disorders | ||||||
| Nausea | 20 (37.0) | 8 (53.3) | 8 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Vomiting | 12 (22.2) | 6 (40.0) | 4 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Constipation | 6 (11.1) | 1 (6.7) | 4 (12.5) | 1 (1.9) | 1 (6.7) | 0 (0.0) |
| Diarrhea | 6 (11.1) | 2 (13.3) | 4 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| General disorders and administration site conditions | ||||||
| Chills | 22 (40.7) | 10 (66.7) | 8 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Fatigue | 19 (35.2) | 9 (60.0) | 8 (25.0) | 2 (3.7) | 0 (0.0) | 1 (3.1) |
| Pyrexia | 8 (14.8) | 3 (20.0) | 3 (9.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Investigations | ||||||
| Weight decreased | 7 (13.0) | 4 (26.7) | 2 (6.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 11 (20.4) | 2 (13.3) | 6 (18.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 6 (11.1) | 2 (13.3) | 4 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Back pain | 6 (11.1) | 2 (13.3) | 2 (6.3) | 2 (3.7) | 1 (6.7) | 0 (0.0) |
| Nervous system disorders | ||||||
| Headache | 8 (14.8) | 4 (26.7) | 4 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Dizziness | 7 (13.0) | 2 (13.3) | 3 (9.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Vascular disorders | ||||||
| Hypertension | 7 (13.0) | 3 (20.0) | 3 (9.4) | 2 (3.7) | 0 (0.0) | 1 (3.1) |
Abbreviations: ICOS, inducible T‐cell costimulatory; PD‐1, programmed cell death protein 1.
Data for combination partners were pooled for both formulations due to limited sample sizes and to specifically evaluate the effect of the two formulations on the safety profile of GSK1795091. Combination partners included GSK3174998 (anti‐OX40 monoclonal antibody), GSK3359609 (anti‐ICOS monoclonal antibody), or pembrolizumab (anti–PD‐1 monoclonal antibody).
Data shown for patients who received either formulation alone. The seven patients who switched formulation during the study and received both formulations are included in the total and are not shown separately by formulation.