Table 2.

Median OS, PFS and ORRs according to subgroups

	n	Median OS (95% CI)	P	HR (95% CI)	Median PFS (95% CI)	P	HR (95% CI)	ORRa (%)	P
Bellmunt risk factorsb			<0.001			<0.001			<0.001
0	296	17.9 (12.7-NR)		1	4.1 (3.5-4.4)		1	19
1	383	8.9 (7.5-10.9)		1.8 (1.4-2.2)	2.3 (2.1-2.8)		1.3 (1.1-1.6)	14
2-3	265	3.3 (2.7-4)		4.3 (3.4-5.4)	2 (1.9-2.1)		2.3 (1.9-2.8)	7
Previous therapy			0.056			0.162			0.095
Cisplatin-based	581	9.4 (8.1-10.9)		1	2.3 (2.1-2.5)		1	15
Carboplatin-based	388	7.5 (6.4-9.2)		1.2 (0.9-1.4)	2.2 (2.1-2.4)		1.1 (0.9-1.3)	11
Previous lines			0.232			0.394			0.084
0	369	9.7 (7.5-11.9)		1	2.2 (2.1-2.9)		1	16
1-3	600	8.3 (7.2-9.4)		1.1 (0.9-1.3)	2.2 (2.1-2.4)		1.1 (0.9-1.2)	12
PD-L1 expressionc			0.002			<0.001			<0.001
IC0-1	647	7.75 (6.5-9)		1	2.1 (2.1-2.3)		1	10
IC2-3	257	11.6 (8.8-18.8)		0.7 (0.6-0.9)	2.6 (2.1-4.1)		0.8 (0.6-0.9)	21
TFLC (months)			<0.001			<0.001			<0.001
0-3	353	6.7 (5.4-7.8)		1	2.1 (2.1-2.2)		1	8
3-6	240	7.5 (5.7-9.9)		0.9 (0.7-1.1)	2.1 (2.1-2.3)		0.9 (0.8-1.8)	12
6-9	172	10.6 (8.4-18)		0.7 (0.5-0.9)	2.5 (2.2-4.1)		0.7 (0.6-0.9)	19
9-12	96	NR (9.9-NR)		0.5 (0.3-0.7)	4.8 (2.5-6.5)		0.6 (0.4-0.8)	24
>12	108	11 (7.75-NR)		0.6 (0.5-0.8)	3.7 (2.2-4.2)		0.7 (0.6-0.9)	15
Neoadjuvant/adjuvant			0.013			0.139			0.077
No	506	7.8 (6.6-9)		1	2.2 (2.1-2.3)		1	11
Yes	463	10.2 (8.3-12.4)		0.8 (0.7-0.9)	2.3 (2.1-3.2)		0.9 (0.8-1.04)	15

CI, confidence interval; HR, hazard ratio; IC, immune cell; NR, not reached; ORR, objective response rates; OS, overall survival; PD-L1, programmed death-ligand 1; PFS, progression-free survival; TFLC, time from last chemotherapy.

^aORR by RECIST version 1.1.

^bBellmunt risk factors: ECOG performance status ≥1, haemoglobin <10 g/dl and presence of liver metastasis.⁸

^cIC0, expression on <1% of tumour-infiltrating ICs; IC1, expression on 1% to <5% of tumour-infiltrating ICs; IC2/3, expression on ≥5% of tumour-infiltrating ICs.