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. Author manuscript; available in PMC: 2023 Dec 13.
Published in final edited form as: Clin Cancer Res. 2023 Jun 13;29(12):2210–2219. doi: 10.1158/1078-0432.CCR-22-3313

Table 2:

Treatment-related AEs occurring in at least 5% of patients in the eganelisib + nivolumab combination therapy cohorta

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.

a

Eganelisib was administered once daily and nivolumab as 240 mg Q2W or 480 mg Q4W.

b

Grade 3 events of dermatitis acneiform (n=1) and joint effusion (n=1) not shown.

c

All events were grade 3 except for grade 4 ALT increased (n=1). Grade 3 event of abdominal pain (n=1) not shown.

d

All events were grade 3 except for grade 4 AST increased (n=1), transaminases increased (n=1), and lymphocyte count decreased (n=1).

e

Includes preferred terms pruritis, rash, rash macular, and rash maculopapular.