Table 2.
Variable | Vorolanib + Pembro | Vorolanib + Nivo | All patients (n = 16) | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Vorolanib 300 mg + pembro (n = 3) | Vorolanib 400 mg + pembro (n = 6) | Vorolanib 300 mg + nivo (n = 4) | Vorolanib 400 mg + nivo (n = 3) | |||||||
All grades, n | Grade 3–4, n | All grades, n | Grade 3–4, n | All grades, n | Grade 3–4, n | All grades, n | Grade 3–4, n | All grades, n (%) | Grade 3–4, n (%) | |
Lymphopenia | 3 | 1 | 2 | 2 | 7 (43.7%) | 1 (6.2%) | ||||
Leukopenia | 2 | 1 | 2 | 1 | 1 | 5 (31.2%) | 2 (12.5%) | |||
Anemia | 1 | 1 | 2 (12.5%) | |||||||
Neutropenia | 2 | 2 | 2 | 2 | 4 (25.0%) | 4 (25.0%) | ||||
Thrombocytopenia | 2 | 1 | 3 (18.7%) | |||||||
Fatigue | 2 | 3 | 5 (31.2%) | |||||||
ALT elevation | 4 | 1 | 1 | 5 (31.2%) | 1 (6.2%) | |||||
AST elevation | 3 | 2* | 1 | 4 (25.0%) | 2 (12.5%) | |||||
ALP elevation | 2 | 1 | 2 (12.5%) | 1 (6.2%) | ||||||
Myalgia | 3 | 1 | 4 (25.0%) | |||||||
Dysgeusia | 1 | 1 | 1 | 3 (18.7%) | ||||||
Hypertension | 1 | 1 | 1 | 2 (12.5%) | 1 (6.2%) | |||||
Proteinuria | 3 | 3 (18.7%) | ||||||||
Hair color change | 2 | 2 (12.5%) | ||||||||
Anorexia/weight loss | 2 | 2 (12.5%) | ||||||||
Diarrhea | 1 | 1 | 1 | 2 (12.5%) | 1 (6.2%) | |||||
Hypothyroidism/TSH elevation | 1 | 1 | 2 (12.5%) | |||||||
Rectal hemorrhage | 1* | 1 (6.2%) | 1 (6.2%) | |||||||
Pancreatitis or amylase/lipase elevation | 1 | 1 | 2 (12.5%) | 2 (12.5%) | ||||||
Skin Rash | 1 | 1 | 1* | 2 (12.5%) | 1 (6.2%) | |||||
Peripheral sensory neuropathy | 1 | 1 | 2 (12.5%) | |||||||
Pruritis | 1 | 1 | 2 (12.5%) |
Data are number (n) and include percent (%) when indicated. Treatment-related adverse events experienced by two or more patients are listed in this table. Dose-limiting toxicities observed in 3 patients are also included and delineated by (*). All adverse events were assessed and reported according to the revised National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
ALP: alkaline phosphatase elevation, ALT alanine aminotransferase, AST aspartate aminotransferase, TSH thyroid stimulating hormone