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. 2022 Jan 5;71(8):1897–1908. doi: 10.1007/s00262-021-03102-3

Table 3.

Response and survival data in each tumor type in phase 1b (N = 176)

Sugemalimab monotherapy Sugemalimab in combination with chemotherapy
CC/GBC
(N = 29)
HCC
(≥ 2L)
(N = 19)
MSI-H/dMMR
(≥ 2L)
(N = 21)
GAC/GEJAC (1L)
(N = 29)
ESCC (1L)
(N = 37)
Non-squamous NSCLC (1L)
(N = 21)
Squamous NSCLC (1L)
(N = 20)
PR*, n (%) 2 (6.9) 2 (10.5) 8 (38.1) 18 (62.1) 25 (67.6) 10 (47.6) 15 (75.0)
SD, n (%) 9 (31.0) 1 (5.3) 3 (14.3) 6 (20.7) 8 (21.6) 9 (42.9) 4 (20.0)
PD, n (%) 14 (48.3) 12 (63.2) 8 (38.1) 3 (10.3) 2 (5.4) 2 (9.5) 0
NA, n (%) 4 (13.8) 4 (21.1) 2 (9.5) 2 (6.9) 2 (5.4) 0 1 (5.0)
ORR, % 6.9 10.5 38.1 62.1 67.6 47.6 75.0
DCR, % 37.9 15.8 52.4 82.8 89.2 90.5 95.0
Median DoR, months 5.4 4.5 13.8 11.3 8.7 6.4
(95% CI) (2.8, 8.0) (2.2, 6.9) (2.1, –) (3.9, –) (6.2, –) (1.8, –) (6.2, –)
Median PFS, months 2.2 2.1 4.1 8.3 9.0 6.5 8.4
(95% CI) (2.0, 4.2) (1.4, 2.1) (2.0, 15.8) (4.8, 13.3) (4.4, –) (4.4, 11.7) (8.2, –)
Median OS, months 11.0 7.1 17.0
(95% CI) (6.4, 16.1) (2.3, 18.7) (14.6, –) (12.1, –) (9.7, –) (10.4, –) (13.9, –)

 ≥ 2L, second-line or after; 1L, first-line; CC/GBC, cholangiocarcinoma or gallbladder carcinoma; HCC, hepatocellular carcinoma; MSI-H/dMMR, solid tumors with MSI-H/dMMR phenotype; GAC/GEJAC, gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; ESCC, esophageal squamous cell carcinoma; NSCLC, non-small cell lung cancer. PR, partial response; SD, stable disease; PD, progressive disease; NA, patient do not have any assessment post-baseline; ORR, objective response rate; DCR, disease control rate; DoR, duration of response; PFS, progression-free survival; OS, overall survival

*Response was assessed in accordance with the Response Evaluation Criteria in Solid Tumors version 1.1. Responses were unconfirmed