Table 3.
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