Table 1. Baseline Characteristics of Patients With Microsatellite Instability–High Advanced Gastric or Gastroesophageal Junction Cancer by Line of Therapy.
| Characteristic | Patients, No. (%) | |||||
|---|---|---|---|---|---|---|
| KEYNOTE-059a | KEYNOTE-061b | KEYNOTE-062c | ||||
| Pembrolizumab | Pembrolizumab | Chemotherapy | Pembrolizumab | Pembrolizumab plus chemotherapy | Chemotherapy | |
| Total patients, No. | 7 | 15 | 12 | 14 | 17 | 19 |
| Age, median (range), y | 62 (51-89) | 67 (36-76) | 63 (43-75) | 62 (39-74) | 67 (59-83) | 69 (31-85) |
| Male sex | 6 (85.7) | 7 (46.7) | 8 (66.7) | 7 (50.0) | 13 (76.5) | 13 (68.4) |
| Location | ||||||
| Australia, Europe, and North America | 2 (28.6) | 10 (66.7) | 7 (58.3) | 10 (71.4) | 11 (64.7) | 14 (73.7) |
| Asia | 1 (14.3) | 4 (26.7) | 3 (25.0) | 4 (28.6) | 4 (23.5) | 2 (10.5) |
| Other region | 4 (57.1) | 1 (6.7) | 2 (16.7) | 0 | 2 (11.8) | 3 (15.8) |
| ECOG performance status | ||||||
| 0 | 4 (57.1) | 5 (33.3) | 4 (33.3) | 7 (50.0) | 7 (41.2) | 7 (36.8) |
| 1 | 3 (42.9) | 10 (66.7) | 8 (66.7) | 7 (50.0) | 10 (58.8) | 12 (63.2) |
| Cancer type | ||||||
| Metastatic | 6 (85.7) | 14 (93.3) | 11 (91.7) | 13 (92.9) | 15 (88.2) | 16 (84.2) |
| Stomach | 5 (71.4) | 11 (73.3) | 10 (83.3) | 13 (92.9) | 13 (76.5) | 16 (84.2) |
| Gastroesophageal junction adenocarcinoma | 2 (28.6) | 4 (26.7) | 2 (16.7) | 1 (7.1) | 4 (23.5) | 3 (15.8) |
| Diffuse subtype adenocarcinoma | 3 (42.9) | 4 (26.7) | 2 (16.7) | 4 (28.6) | 9 (52.9) | 6 (31.6) |
| Intestinal subtype adenocarcinoma | 3 (42.9) | 0 | 4 (33.3) | 8 (57.1) | 5 (29.4) | 7 (36.8) |
| Mixed/unknown subtype | 1 (14.3) | 11 (73.3) | 6 (50.0) | 2 (14.3) | 3 (17.6) | 6 (31.6) |
| Previous lines of therapy | ||||||
| 0 | 0 | 0 | 0 | 14 (100) | 17 (100) | 19 (100) |
| 1 | 0 | 15 (100) | 12 (100) | 0 | 0 | 0 |
| ≥2 | 7 (100) | 0 | 0 | 0 | 0 | 0 |
| PD-L1 CPS | ||||||
| ≥1 | 5 (71.4) | 13 (86.7) | 11 (91.7) | 14 (100) | 17 (100) | 19 (100) |
| ≥10 | 2 (28.6) | 8 (53.3) | 5 (41.7) | 11 (78.6) | 11 (64.7) | 10 (52.6) |
Abbreviations: CPS, combined positive score; ECOG, Eastern Cooperative Oncology Group; PD-L1, programmed cell death 1 ligand 1.
a
A total of 174 of 259 patients enrolled in KEYNOTE-059 who had tumors that were evaluable for microsatellite instability–high status were included.
b
A total of 514 of 592 patients enrolled in KEYNOTE-061 who had tumors that were evaluable for microsatellite instability–high status were included.
c
A total of 682 of 763 patients enrolled in KEYNOTE-062 who had tumors that were evaluable for microsatellite instability–high status were included.