TABLE 2.
Summary of tumor response per RECIST Version 1.1 by BICR
| Pembrolizumab +pemetrexed‐platinum (n = 25) | Placebo + pemetrexed‐platinum (n = 15) | |
|---|---|---|
| Objective response rate, % (95% CI) | 56 (34.9 to 75.6) | 33 (11.8 to 61.6) |
| Complete response | 1 (4) | 0 (0) |
| Partial response | 13 (52) | 5 (33) |
| Stable diseasea | 9 (36) | 8 (53) |
| Progressive disease | 0 (0) | 2 (13) |
| Not evaluableb | 2 (8) | 0 (0) |
| Time to response, median (range), monthsc | 1.4 (1.2 to 3.0) | 1.4 (1.2 to 4.9) |
| Duration of response, median (range), months c , d | 13.6 (3.3+ to 19.6) | 9.7 (3.4 to 26.4+) |
| Kaplan‐Meier estimate of patients with extended duration of response, % c , d | ||
| ≥12 mo | 61.9 | 40.0 |
Data are n (%) unless otherwise noted.
+, no progressive disease at time of last assessment.
BICR, blinded, independent central radiologic review; RECIST, Response Evaluation Criteria in Solid Tumors.
a
Includes stable disease and noncomplete response/nonprogressive disease.
b
Postbaseline assessments were not evaluable or complete response/partial response/stable disease was <6 wk from randomization.
c
Assessed in patients with a best objective response of confirmed complete or partial response.
d
Estimated using product‐limit (Kaplan‐Meier) method for censored data.