The risk and benefit of nivolumab treatment in cancer

Study	Underlying malignancy	No. of patients enrolled	Median OS (95% CI), month	HR (95% CI)	P value	No. of patients (safety)	FAE	SAE
Borghaei,2015 [6]	Lung cancer	292	12.2(9.7–15.0)	0.73(0.59–0.89)	0.002	287	1	21
Borghaei,2015 [6]	Lung cancer	290	9.4(8.1–10.7)	0.73(0.59–0.89)	0.002	268	1	53
Brahmer, 2015 [7]	Lung cancer	135	9.2(7.3–13.3)	0.59(0.44–0.79)	< 0.001	131	0	9
Brahmer, 2015 [7]	Lung cancer	137	6.0(5.1–7.3)	0.59(0.44–0.79)	< 0.001	129	3	31
Carbone, 2017 [8]	Lung cancer	271	14.4(11.7–17.4)	1.02(0.80–1.30)	NR	267	2	46
Carbone, 2017 [8]	Lung cancer	270	13.2(10.7–17.1)	1.02(0.80–1.30)	NR	263	3	48
Ferris, 2016 [10]	Head and neck cancer	240	7.5(5.5–9.1)	0.70(0.51–0.96)	0.01	236	2	NR
Ferris, 2016 [10]	Head and neck cancer	121	5.1(4.0–6.0)	0.70(0.51–0.96)	0.01	111	1	NR
Kang, 2017 [9]	G/GJC	330	5.3(4.6–6.4)	0.63(0.51–0.78)	< 0.0001	330	5	33
Kang, 2017 [9]	G/GJC	163	4.1(3.4–4.9)	0.63(0.51–0.78)	< 0.0001	161	2	8
Motzer, 2015 [11]	Renal cancer	410	25.0(21.8-not reached)	0.73(0.57–0.93)	0.002	406	0	NR
Motzer, 2015 [11]	Renal cancer	411	19.6(17.6–23.1)	0.73(0.57–0.93)	0.002	397	2	NR
Robert, 2015 [12]	Melanoma	210	Not reached	0.42(0.25–0.73)	< 0.001	206	0	19
Robert, 2015 [12]	Melanoma	205	10.8(9.3–12.1)	0.42(0.25–0.73)	< 0.001	205	0	18
Weber, 2017 [13]	Melanoma	453	NR	NR	NR	452	0	NR
Weber, 2017 [13]	Melanoma	453	NR	NR	NR	453	2	NR
Wolchok, 2017 [14]	Melanoma	314	Not reached	NR	NR	313	2	NR
		316	37.6(29.1-not reached)	NR	NR	313	1	NR
		315	19.9(16.9–24.6)	NR	NR	311	1	NR
D’angelo, 2018 [15]	Sarcoma	43	10.7(5.5–15.4)	NR	NR	42	0	8
D’angelo, 2018 [15]	Sarcoma	42	14.3(9.6-not reached)	NR	NR	42	0	11
Long, 2018 [16]	Melanoma	35	NR	NR	NR	35	0	16
		25	NR	NR	NR	25	0	1
		16	NR	NR	NR	16	0	2
Motzer, 2015 [19]	Renal cancer	60	18.2	NR	NR	59	0	NR
		54	25.5	NR	NR	54	0	NR
		54	24.7	NR	NR	54	0	NR
Hamanishi, 2015 [18]	Ovarian cancer	20	20.0	NR	NR	20	0	5
Hida, 2017 [29]	Lung cancer	35	16.3(12.4–25.4)	NR	NR	35	0	3
Kudo, 2017 [30]	Esophageal cancer	65	10.8(7.4–13.3)	NR	NR	65	0	10
Maruyama, 2017 [31]	Hodgkin lymphoma	17	NR	NR	NR	17	0	6
Nishio, 2017 [32]	Lung cancer	76	17.1(13.3–23.0)	NR	NR	76	0	15
Overman, 2017 [33]	Colorectal cancer	74	NR	NR	NR	74	0	9
Rizvi, 2015 [34]	Lung cancer	117	8.2(6.1–10.9)	NR	NR	117	2	NR
Yamazaiki, 2017 [35]	Melanoma	24	NR	NR	NR	24	0	4
Younes, 2016 [36]	Hodgkin lymphoma	80	NR	NR	NR	80	0	5

Abbreviation: G/GJC gastric and gastro-esophageal junction cancer FAE, fatal adverse event SAE Serious adverse event; OS overall survival; CI confidence interval; HR hazard ratio; NR not reported