TABLE 2.
Summary of confirmed objective response per RECIST version 1.1 by investigator assessment
| PD‐L1 CPS ≥1 | All‐Comer | PD‐L1 CPS ≥10 | ||||
|---|---|---|---|---|---|---|
| Pembrolizumab | Placebo | Pembrolizumab | Placebo | Pembrolizumab | Placebo | |
| N = 30 | N = 21 | N = 35 | N = 22 | N = 15 | N = 10 | |
| Objective response rate, % (95% CI) a | 80 (61–92) | 71 (48–89) | 77 (60–90) | 68 (45–86) | 87 (60–98) | 60 (26–88) |
| Difference vs. placebo, % (95% CI) b | 9 (−15 to 34) | 9 (−14 to 33) | 27 (−8 to 59) | |||
| Best overall response, n (%) | ||||||
| Complete response | 12 (40) | 5 (24) | 12 (34) | 5 (23) | 6 (40) | 1 (10) |
| Partial response | 12 (40) | 10 (48) | 15 (43) | 10 (46) | 7 (47) | 5 (50) |
| Stable disease | 5 (17) | 5 (24) | 7 (20) | 6 (27) | 2 (13) | 3 (30) |
| Progressive disease | 1 (3) | 0 | 1 (3) | 0 | 0 | 0 |
| Not evaluable | 0 | 0 | 0 | 0 | 0 | 0 |
| No assessment | 0 | 1 (5) | 0 | 1 (5) | 0 | 1 (10) |
| Median time to response (range), months | 2.1 (1.9–10.2) | 2.1 (1.9–4.2) | 2.1 (1.9–10.2) | 2.1 (1.9–4.2) | 2.2 (1.9–4.4) | 2.0 (1.9–2.2) |
| Median duration of response (range), months c |
NR (4.0+ to 24.1+) |
10.5 (4.2 to 21.7+) |
NR (4.0+ to 24.1+) |
10.5 (4.2 to 21.7+) |
NR (4.0+ to 4.1+) |
9.4 (8.2 to 18.7+) |
Note: “+” indicates there was no progressive disease by the time of last disease assessment.
Abbreviations: CPS, combined positive score; PD‐L1, programmed death ligand 1; RECIST, Response Evaluation Criteria in Solid Tumors.
a
Includes patients with best objective response with confirmation as complete response or partial response.
b
Based on Miettinen and Nurminen method.
c
From product‐limit (Kaplan–Meier) method for censored data.