Table 4

Tumor response in cohort A1

Cohort A1*Cohort A1 by tumor PD-L1 expression†
Overall
(N=198‡)
ECOG PS 2
(n=139§)
Asymptomatic untreated brain metastases
(n=49¶)
PD-L1 ≥1%
(n=76)
PD-L1 <1%
(n=95)
Objective response rate, n (%)**
95% CI
51 (25.8)
19.8 to 32.4
29 (20.9)
14.4 to 28.6
16 (32.7)
19.9 to 47.5
21 (27.6)
18.0 to 39.1
23 (24.2)
16.0 to 34.1
Complete response, n (%)00000
Partial response, n (%)51 (25.8)29 (20.9)16 (32.7)21 (27.6)23 (24.2)
Stable disease, n (%)73 (36.9)55 (39.6)14 (28.6)27 (35.5)34 (35.8)
Progressive disease, n (%)37 (18.7)26 (18.7)12 (24.5)10 (13.2)23 (24.2)
Not evaluable, n (%)37 (18.7)29 (20.9)7 (14.3)18 (23.7)15 (15.8)
Time to objective response, median (range), months2.6
(1.1–13.8)
2.6
(1.1–10.0)
2.6
(1.2–13.8)
1.4
(1.2–5.6)
2.6
(1.1–13.8)
Duration of objective response, median (95% CI), months13.5
(9.6 to 27.4)
15.5
(9.8 to 29.3)
12.6
(6.7 to NR)
24.8
(10.0 to NR)
12.4
(4.3 to 34.6)
Patients with duration of response of at least, % (95% CI)
6 months79 (65 to 88)79 (60 to 90)86 (54 to 96)95 (71 to 99)68 (44 to 83)
12 months55 (40 to 68)61 (41 to 76)55 (26 to 77)69 (43 to 85)52 (29 to 71)
18 months39 (25 to 53)43 (24 to 60)39 (15 to 64)53 (29 to 72)36 (16 to 56)
24 months39 (25 to 53)43 (24 to 60)39 (15 to 64)53 (29 to 72)36 (16 to 56)
30 months29 (16 to 43)28 (12 to 47)39 (15 to 64)37 (17 to 58)36 (16 to 56)
36 months23 (10 to 39)NA39 (15 to 64)37 (17 to 58)NA
  • *Patients belonging to multiple subgroups are included in each of the subgroups.

  • †Tumor PD-L1 expression was not evaluable in 27 patients in cohort A1.

  • ‡Includes all special populations: ECOG PS 2, untreated brain metastases, renal impairment, hepatic impairment, and positive HIV status.

  • §Includes five patients with untreated brain metastases, one with renal impairment, and three with hepatic impairment.

  • ¶Includes five patients with ECOG PS 2 and one patient with positive HIV status.

  • **Defined as the sum of complete and partial responses per Response Evaluation Criteria in Solid Tumors V.1.1.

  • ECOG PS, Eastern Cooperative Oncology Group performance status; NA, not achieved; NR, not reached; PD-L1, programmed death ligand 1.