Table 2

Summary of TRAEs by MedDRA preferred term (≥10% of patients and the associated maximum severity of the safety evaluable population)

TRAE, n (%)Group A: itacitinib+epacadostatGroup B: itacitinib+parsaclisib
Part 1a
Dose-escalation
Group A
(n=12)
Part 1b
Dose-expansion
Groups A-1 and A-2
(n=35)
Part 1a
Dose-escalation
Group B
(n=42)
Part 1b
Dose-expansion
Groups B-1 and B-2
(n=23)
Part 2
Dose-expansion
Groups B-3, B-4, and B-5
(n=30)
Any gradeGrade ≥3Any gradeGrade ≥3Any gradeGrade ≥3*Any gradeGrade ≥3Any gradeGrade ≥3
Fatigue1 (8.3)0 (0)17 (48.6)2 (5.7)9 (21.4)0 (0)8 (34.8)0 (0)9 (30.0)2 (6.7)
Nausea2 (16.7)0 (0)10 (28.6)2 (5.7)5 (11.9)0 (0)4 (17.4)0 (0)7 (23.3)0 (0)
Vomiting3 (25.0)0 (0)6 (17.1)1 (2.9)2 (4.8)0 (0)3 (13.0)0 (0)3 (10.0)0 (0)
Decreased appetite0 (0)0 (0)3 (8.6)0 (0)5 (11.9)0 (0)3 (13.0)0 (0)4 (13.3)0 (0)
Anemia0 (0)0 (0)2 (5.7)0 (0)0 (0)0 (0)1 (4.3)0 (0)5 (16.7)1 (3.3)
Diarrhea1 (8.3)0 (0)5 (14.3)2 (5.7)6 (14.3)0 (0)2 (8.7)0 (0)4 (13.3)0 (0)
Pyrexia3 (25.0)0 (0)5 (14.3)1 (2.9)9 (21.4)0 (0)3 (13.0)0 (0)1 (3.3)0 (0)
Dizziness0 (0)0 (0)1 (2.9)0 (0)0 (0)0 (0)0 (0)0 (0)3 (10.0)0 (0)
Chills2 (16.7)0 (0)1 (2.9)0 (0)5 (11.9)0 (0)2 (8.7)0 (0)0 (0)0 (0)
Neck pain0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)3 (10.0)0 (0)
Thrombocytopenia0 (0)0 (0)4 (11.4)1 (2.9)0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)
  • *One patient experienced a DLT of grade 3 aseptic meningitis; the DLT resolved when the study drugs (itacitinib and parsaclisib) were withdrawn.

  • DLT, dose-limiting toxicity; MedDRA, Medical Dictionary for Regulatory Activities; TRAE, treatment-related adverse event.