Table 2. Clinical Activity of Nivolumab versus Docetaxel in Patients with Advanced Squamous-Cell Non–Small-Cell Lung Cancer^*.

Variable	Nivolumab (N = 135)	Docetaxel (N = 137)
Objective response†
No. of patients	27	12
% of patients (95% CI)	20 (14–28)	9 (5–15)
Estimated odds ratio (95% CI)	2.6 (1.3–5.5)
P value	0.008
Best overall response — no. (%)
Complete response	1 (1)	0
Partial response	26 (19)	12 (9)
Stable disease	39 (29)	47 (34)
Progressive disease	56 (41)	48 (35)
Could not be determined	13 (10)	30 (22)
Time to response — mo‡§
Median	2.2	2.1
Range	1.6–11.8	1.8–9.5
Duration of response — mo‡¶
Median	NR	8.4
Range	2.9 to 20.5+	1.4+ to 15.2+

^*NR denotes not reached.

^†Confirmed complete and partial responses were assessed by the investigator according to the Response Evaluation Criteria in Solid Tumors, version 1.1. The confidence interval is based on the Clopper–Pearson method. The analysis was stratified according to geographic region (United States or Canada vs. Europe vs. rest of the world) and prior paclitaxel therapy (yes vs. no). The strata-adjusted odds ratio (nivolumab vs. docetaxel) and the two-sided P value were calculated with the use of the stratified Cochran–Mantel–Haenszel method.

^‡The analysis was performed with data from all the patients who had a response (27 patients in the nivolumab group and 12 in the docetaxel group).

^§The time to response was defined as the time from randomization to the date of 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 from the date of first response to the date of first documented disease progression, death, or last tumor assessment that could be evaluated. The + symbol indicates a censored value. The value of 1.4 was censored owing to the start of subsequent therapy in one patient, and the other values were censored because the response was ongoing at the time of the analysis.