Table 2:
n (%) | Eganelisib dose escalation + nivolumab (Part C) | Eganelisib + nivolumab dose expansion (Parts E-H: eganelisib 40 mg) (n=149) | ||||||
---|---|---|---|---|---|---|---|---|
| ||||||||
20 mg (n=7) | 30 mg (n=12) | 40 mg (n=12) | ||||||
| ||||||||
Any grade | G≥3 | Any grade | G≥3b | Any grade | G≥3c | Any grade | G≥3d | |
Any treatment-related TEAE | 4 (57) | 1 (14) | 9 (75) | 4 (33) | 9 (75) | 5 (42) | 110 (74) | 58 (39) |
Rashe | 1 (14) | 1(14) | 5 (42) | 1 (8) | 8 (67) | 3 (25) | 77 (52) | 21 (14) |
AST increased | 1 (8) | - | 5 (42) | 5 (42) | 39 (26) | 21 (14) | ||
ALT increased | 1 (8) | - | 5 (42) | 4 (33) | 36 (24) | 16 (11) | ||
Fatigue | 2 (17) | - | 28 (19) | - | ||||
Nausea | 1 (14) | - | 1 (8) | 21 (14) | 2 (1) | |||
Pyrexia | 1 (8) | - | 1 (8) | - | 21 (14) | 2 (1) | ||
Blood ALP increased | 2 (17) | - | 13 (9) | 6 (4) | ||||
Decreased appetite | 12 (8) | - | ||||||
Diarrhea | 2 (17) | - | 1 (8) | - | 9 (6) | 1 (1) | ||
Vomiting | 1 (14) | - | 1 (8) | - | 1 (8) | - | 9 (6) | 2 (1) |
Chills | 10 (7) | 1 (1) | ||||||
Arthralgia | 9 (6) | - | ||||||
Myalgia | 9 (6) | - | ||||||
Lipase increased | 1 (8) | 1 (8) | 1 (8) | - | 8 (5) | 2 (1) |
Abbreviations: ALT, alanine aminotransferase; AST, alanine aminotransferase; ALP, alkaline phosphatase; G≥3, grade 3 or higher; Q2W, every 2 weeks; Q4W, every 4 weeks; TEAE, treatment-emergent adverse event.
Eganelisib was administered once daily and nivolumab as 240 mg Q2W or 480 mg Q4W.
Grade 3 events of dermatitis acneiform (n=1) and joint effusion (n=1) not shown.
All events were grade 3 except for grade 4 ALT increased (n=1). Grade 3 event of abdominal pain (n=1) not shown.
All events were grade 3 except for grade 4 AST increased (n=1), transaminases increased (n=1), and lymphocyte count decreased (n=1).
Includes preferred terms pruritis, rash, rash macular, and rash maculopapular.