TABLE 2.
Summary of Confirmed Tumor Response Assessed per RECIST Version 1.1 by Blinded Independent Central Review (ITT Population)
| Response | Pembrolizumab Plus Pemetrexed-Platinum (n = 245) | Placebo Plus Pemetrexed-Platinum (n = 247) |
|---|---|---|
| ORR (95% CI), % | 29.0 (23.4 to 35.1) | 27.1 (21.7 to 33.1) |
| Best overall response, No. (%) | ||
| CR | 5 (2.0) | 3 (1.2) |
| PR | 66 (26.9) | 64 (25.9) |
| SDa | 121 (49.4) | 117 (47.4) |
| PD | 37 (15.1) | 52 (21.1) |
| Not evaluableb | 8 (3.3) | 5 (2.0) |
| No assessmentc | 8 (3.3) | 6 (2.4) |
| DOR,d median (range), months | 6.3 (2.3-40.8+)e | 5.6 (1.8+-40.6+)e |
| DOR ≥9 months,d No. (%) | 23 (34.0) | 13 (22.9) |
| Time to response, median (range), months | 1.5 (1.2-9.7) | 1.5 (1.2-25.3) |
Abbreviations: CR, complete response; DOR, duration of response; ITT, intention to treat; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease.
a
Stable disease includes stable disease, non-CR/non-PD, and no evidence of disease (no lesions identified at baseline or postbaseline assessments).
b
Postbaseline assessment(s) available but not evaluable or CR/PR/SD <6 weeks from random assignment.
c
No postbaseline assessment available for response evaluation.
d
On the basis of Kaplan-Meier estimate.
e
The + indicates no progressive disease by the time of last disease assessment.