Table 2. Outcomes in Patients With Advanced Gastric or Gastroesophageal Junction Cancer by Line of Therapy.
| Outcome | KEYNOTE-059a | KEYNOTE-061b | KEYNOTE-062c | |||
|---|---|---|---|---|---|---|
| Pembrolizumab | Pembrolizumab | Chemotherapy | Pembrolizumab | Pembrolizumab plus chemotherapy | Chemotherapy | |
| All patients | ||||||
| Total patients, No. | 259 | 296 | 296 | 256 | 257 | 250 |
| Objective response rate, % (95% CI) | 11.6 (8.0-16.1) | 11.1 (7.8-15.3) | 12.5 (9.0-16.8) | 14.8 (10.7-19.8) | 48.6 (42.4-54.9) | 37.2 (31.2-43.5) |
| Best overall response rate, % | ||||||
| Complete | 3.5 | 2.4 | 2.4 | 3.5 | 7.4 | 5.6 |
| Partial | 8.1 | 8.8 | 10.1 | 11.3 | 41.2 | 31.6 |
| Stable disease | 16.2 | 22.6 | 46.3 | 27.0 | 28.8 | 41.6 |
| Progressive disease | 56.0 | 51.7 | 22.3 | 41.0 | 7.4 | 8.4 |
| Duration of response, median (range), mo | 16.1 (2.4-34.9d) | 18.0 (1.4d-26.0d) | 5.5 (1.3d-17.7) | 13.7 (1.4d-33.6d) | 6.8 (1.4d-34.7d) | 6.8 (1.4d-30.4d) |
| Survival, median (95% CI), mo | ||||||
| Progression-free | 2.0 (2.0-2.0) | 1.5 (1.4-1.6) | 4.1 (3.2-4.2) | 2.0 (1.5-2.8) | 6.9 (5.8-7.3) | 6.4 (5.7-7.1) |
| Overall | 5.5 (4.2-6.7) | 6.7 (5.4-8.9) | 8.3 (7.7-8.8) | 10.6 (7.7-13.8) | 12.5 (10.8-13.9) | 11.1 (9.2-12.8) |
| Estimated overall survival rate, % (95% CI) | ||||||
| 12 mo | 25 (NA) | 34 (29-39) | 28 (23-33) | 47 (41-53) | 53 (47-59) | 46 (39-52) |
| 24 mo | 13 (NA) | 18 (13-23) | 9 (6-13) | 27 (21-32) | 24 (19-30) | 19 (15-24) |
| Patients with MSI-H tumors | ||||||
| Total patients, No. | 7 | 15 | 12 | 14 | 17 | 19 |
| Objective response rate, % (95% CI) | 57.1 (18.4-90.1) | 46.7 (21.3-73.4) | 16.7 (2.1-48.4) | 57.1 (28.9-82.3) | 64.7 (38.3-85.8) | 36.8 (16.3-61.6) |
| Best overall response rate, % | ||||||
| Complete | 28.6 | 6.7 | 8.3 | 7.1 | 35.3 | 10.5 |
| Partial | 28.6 | 40.0 | 8.3 | 50.0 | 29.4 | 26.3 |
| Stable disease | 14.3 | 40.0 | 58.3 | 21.4 | 17.6 | 42.1 |
| Progressive disease | 0 | 6.7 | 0 | 14.3 | 0 | 10.5 |
| Duration of response, median (range), mo | NR (20.0d-26.8d) | NR (5.5-26.0d) | NR (2.2d-12.2d) | 21.2 (1.4d-33.6d) | NR (1.6d-34.5d) | 7.0 (2.0-30.4d) |
| Survival, median (95% CI), mo | ||||||
| Progression-free | NR (1.1-NR) | 17.8 (2.7-NR) | 3.5 (2.0-9.8) | 11.2 (1.5-NR) | NR (3.6-NR) | 6.6 (4.4-8.3) |
| Overall | NR (1.1-NR) | NR (5.6-NR) | 8.1 (2.0-16.7) | NR (10.7-NR) | NR (3.6-NR) | 8.5 (5.3-20.8) |
| Estimated overall survival rate, % (95% CI) | ||||||
| 12 mo | 71 (NA) | 73 (44-89) | 25 (6-50) | 79 (47-92) | 71 (43-87) | 47 (24-67) |
| 24 mo | 57 (NA) | 59 (31-79) | NA | 71 (41-88) | 65 (38-82) | 26 (10-57) |
Abbreviations: MSI-H, microsatellite instability–high; NA, not available; NR, not reached.
a
Patients enrolled in KEYNOTE-059 had 2 or more previous lines of therapy.
b
Patients enrolled in KEYNOTE-061 had 1 previous line of therapy.
c
Patients enrolled in KEYNOTE-062 had no previous therapy.
d
Indicates ongoing response.