Table 1

Summary of demographic and baseline characteristics: group A and B (all enrolled patients)

VariableGroup 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)
Median age (range), years63.5 (40–74)62.0 (43–85)61.0 (37–77)60.0 (35–85)62.5 (28–78)
Male, n (%)5 (41.7)16 (45.7)17 (40.5)8 (34.8)19 (63.3)
Race, n (%)
 White/Caucasian10 (83.3)29 (82.9)34 (81.0)18 (78.3)24 (80.0)
 Black/African-American2 (16.7)3 (8.6)6 (14.3)2 (8.7)2 (6.7)
 Other0 (0)3 (8.6)2 (4.8)3 (13.0)4 (13.3)
ECOG PS, n (%)
 04 (33.3)10 (28.6)8 (19.0)4 (17.4)7 (23.3)
 18 (66.7)25 (71.4)34 (81.0)19 (82.6)23 (76.7)
Prior therapy, n (%)
 Radiotherapy6 (50.0)19 (54.3)26 (61.9)14 (60.9)24 (80.0)
 Surgery10 (83.3)29 (82.9)37 (88.1)19 (82.6)26 (86.7)
 Systemic therapy12 (100)35 (100)41 (97.6)23 (100)29 (96.7)
Median lines of prior systemic therapy (range)*4.5 (1–12)4.0 (1–11)4.0 (1–13)3.0 (1–7)3.0 (1–7)
Tumor type, n (%)
 Endometrium adenocarcinoma2 (16.7)0 (0)3 (7.1)7 (30.4)0 (0)
 NSCLC1 (8.3)5 (14.3)2 (4.8)6 (26.1)5 (16.7)
 Pancreatic cancer1 (8.3)17 (48.6)4 (9.5)6 (26.1)6 (20.0)
 RCC1 (8.3)1 (2.9)1 (2.4)0 (0)0 (0)
 Breast cancer0 (0)4 (11.4)3 (7.1)1 (4.3)0 (0)
 Melanoma0 (0)4 (11.4)1 (2.4)2 (8.7)0 (0)
 Bladder cancer2 (16.7)1 (2.9)2 (4.8)0 (0)4 (13.3)
 Gastric cancer0 (0)1 (2.9)0 (0)1 (4.3)0 (0)
 CRC1 (8.3)1 (2.9)7 (16.7)0 (0)0 (0)
 HNSCC0 (0)1 (2.9)2 (4.8)0 (0)7 (23.3)
 Other4 (33.3)†0 (0)17 (40.5)‡0 (0)8 (26.7)§
  • *Lines of prior systemic therapy were not counted for one patient in part 1a group B. All regimen start dates are unknown for this patient.

  • †Cholangiocarcinoma, ovarian, and thyroid (n=1 each); other (n=1).

  • ‡Adrenal, cervical, cholangiocarcinoma, mesothelioma, neuroendocrine, ovarian, and small cell lung cancer (n=1 each); salivary, thyroid, and uterine (n=2 each); other (n=4).

  • §Salivary gland (n=7); other (n=1).

  • CRC, colorectal cancer; ECOG PS, Eastern Cooperative Oncology Group performance status; HNSCC, head and neck squamous cell carcinoma; NSCLC, non-small cell lung cancer; RCC, renal cell carcinoma.