Table 2.

Tumor Response in Patients with a PD-L1 Expression Level of 5% or More.^*

Variable	Nivolumab (N = 211)	Chemotherapy (N = 212)
Objective response†
No. of patients with response	55	71
% of patients (95% CI)	26 (20–33)	33 (27–40)
Estimated odds ratio (95% CI)	0.70 (0.46–1.06)
Best overall response — no. (%)
Complete response	4 (2)	1 (<1)
Partial response	51 (24)	70 (33)
Stable disease	81 (38)	100 (47)
Progressive disease	58 (27)	21 (10)
Could not be determined	17 (8)	20 (9)
Time to response — mo‡§
Median	2.8	2.6
Range	1.2–13.2	1.2–9.8
Duration of response — mo‡¶
Median	12.1	5.7
Range	1.7–19.4+	1.4–21.0+

^*Data are based on an August 2, 2016, database lock.

^†Objective response was assessed according to the Response Evaluation Criteria in Solid Tumors, version 1.1, by independent central review. The 95% confidence interval is based on the Clopper-Pearson method. The analysis was stratified according to tumor histologic findings. The strata-adjusted odds ratio was calculated with the use of the Cochran-Mantel-Haenszel method.

^‡The analysis was performed with data from all the patients who had a response (55 patients in the nivolumab group and 71 in the chemotherapy group).

^§The time to response was defined as the time from randomization to the date of the first documented complete or partial response.

^¶Results were calculated with the use of the Kaplan-Meier method. The duration of response was defined as the time between the date of the first response and the date of the first documented event of progression, death, or last tumor assessment that was evaluated before subsequent therapy (data-censoring date). The plus sign indicates that the response was ongoing at the time of data analysis; ongoing responses are censored at the date of the most recent scan obtained before the data analysis.