Table 1.
Summary of confirmed objective response and duration of response (per RECIST 1.1 by BICR) by PD-L1 CPS population with pembrolizumab versus EXTREME in the Japanese population
| PD-L1 CPS ≥ 20 | PD-L1 CPS ≥ 1 | Total population | ||||
|---|---|---|---|---|---|---|
| Pembrolizumab (n = 14) | EXTREME (n = 8) | Pembrolizumab (n = 21) | EXTREME (n = 16) | Pembrolizumab (n = 23) | EXTREME (n = 19) | |
| ORR | 4 (28.6; 8.4–58.1) | 1 (12.5; 0.3–52.7) | 4 (19.0; 5.4–41.9) | 4 (25.0; 7.3–52.4) | 4 (17.4; 5.0–38.8) | 7 (36.8; 16.3–61.6) |
| Best overall response | ||||||
| CR | 1 (7.1) | 0 | 1 (4.8) | 1 (6.3) | 1 (4.3) | 1 (5.3) |
| PR | 3 (21.4) | 1 (12.5) | 3 (14.3) | 3 (18.8) | 3 (13.0) | 6 (31.6) |
| SD | 5 (35.7) | 5 (62.5) | 8 (38.1) | 6 (37.5) | 9 (39.1) | 6 (31.6) |
| PD | 5 (35.7) | 2 (25.0) | 9 (42.9) | 6 (37.5) | 10 (43.5) | 6 (31.6) |
| Median (range) duration of response, months | 8.4 (3.2–73.8 +) | 2.6 | 8.4 (3.2–73.8 +) | 5.5 (2.6–66.5 +) | 8.4 (3.2–73.8 +) | 4.1 (2.0–66.5 +) |
Data are n (%; 95% CI) or n (%). ORR was defined as a best overall response of CR or PR. Duration of response was defined as the time from the first documented evidence of CR or PR until disease progression or death (whichever occurred first)
BICR blinded independent central review, CI confidence interval, CPS combined positive score, CR complete response; ORR objective response rate, PD progressive disease, PD-L1 programmed cell death ligand 1, PR partial response, RECIST Response Evaluation Criteria in Solid Tumors, SD stable disease
aFrom product-limit (Kaplan–Meier) method for censored data; “ + ” indicates that there was no progressive disease by the time of last disease assessment