Table 2

Efficacy outcomes

Efficacy outcomeINCB001158 monotherapyINCB001158+pembrolizumab
Dose escalation (Part 1a—total)Dose expansion (Part 2—total)Dose escalation (Part 1b—total)Dose expansion (Part 3)*
Cohort 3aCohort 3bCohort 3cCohort 3dCohort 3eCohort 3fCohort 3gCohort 3h
Objective response, evaluable n257333121212527132611
 BOR, n (%)
  CR000000001 (7.7)1 (3.8)0
  PR01 (1.4)†2 (6.1)1 (8.3)02 (16.7)02 (7.4)04 (15.4)1 (9.1)
  SD5 (20.0)22 (30.1)8 (24.2)6 (50.0)6 (50.0)2 (16.7)4 (80.0)5 (18.5)2 (15.4)12 (46.2)7 (63.6)
  PD19 (76.0)37 (50.7)21 (63.6)4 (33.3)5 (41.7)7 (58.3)1 (20.0)17 (63.0)9 (69.2)8 (30.8)2 (18.2)
  NE1 (4.0)3 (4.1)1 (8.3)0003 (11.1)01 (3.8)0
  Missing10 (13.7)2 (6.1)01 (8.3)1 (8.3)001 (7.7)01 (9.1)
 ORR, n (%) (95% CI)0
(0 to 13.7)
1 (1.4)
(0 to 7.4)
2 (6.1)
(0.7 to 20.2)
1 (8.3)
(0.2 to 38.5)
0
(0 to 26.5)
2 (16.7)
(2.1 to 48.4)
0
(0 to 52.2)
2 (7.4)
(0.9 to 24.3)
1 (7.7)
(0.2 to 36.0)
5 (19.2)
(6.6 to 39.4)
1 (9.1)
(0.2 to 41.3)
PFS, evaluable n307734121213527132611
 Events, n (%)21 (70.0)58 (75.3)29 (85.3)8 (66.7)10 (83.3)8 (61.5)3 (60.0)22 (81.5)11 (84.6)21 (80.8)8 (72.7)
 Median (95% CI), mo1.8
(1.8 to 1.9)
1.9
(1.8 to 2.1)
2.1
(2.0 to 2.4)
3.9
(1.9 to 15.3)
4.3
(2.0 to 9.0)
2.1
(0.8 to NE)
6.1
(1.6 to NE)
2.1
(2.0 to 2.3)
2.1
(0.8 to 4.7)
4.4
(2.1 to 6.2)
10.2
(1.5 to 10.6)
  • *Part 1c efficacy was summarised together with Part 3 in the combination therapy dose-expansion table according to the tumour types.

  • †This patient had well-differentiated urothelial cancer with negative PD-L1 status and mutations in NRAS, PIK3CA, RAF1, CCNE1, ERBB2 (HER2), TERT, STK11 and RB1.

  • BOR, best overall response; CR, complete response; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease.