Table 2.

Objective response, best overall response, and DCR in all IO-naive patients treated with NIVO + RELA or NIVO + IPI in track 1, and by LAG-3 and PD-L1 expression

		NIVO + RELA group (n = 30)	NIVO + IPI group (n = 30)
Objective response, n (%)		9 (30.0)	6 (20.0)
95% CI		14.7-49.4	7.7-38.6
Best overall response, n (%)
Complete response		1 (3.3)	1 (3.3)
Partial response		8 (26.7)	5 (16.7)
Stable disease		7 (23.3)	11 (36.7)
Progressive disease		12 (40.0)	12 (40.0)
Not assessable/available		2 (6.7)	1 (3.3)
Disease control rate, n (%)a		16 (53.3)	17 (56.7)
95% CI		34.3-71.7	37.4-74.5
Patients with measurable LAG-3 expression, n (%); 95% CI
LAG-3 ≥1%	Objective response	n = 14	n = 15
		6 (42.9); 17.7-71.1	2 (13.3); 1.7-40.5
	Disease control ratea	10 (71.4); 41.9-91.6	9 (60.0); 32.3-83.7
LAG-3 <1%	Objective response	n = 8	n = 5
		1 (12.5); 0.3-52.7	4 (80.0); 28.4-99.5
	Disease control ratea	2 (25.0); 3.2-65.1	4 (80.0); 28.4-99.5
Patients with measurable tumour PD-L1 expression, n (%); 95% CI
PD-L1 ≥1%	Objective response	n = 11	n = 5
		5 (45.5); 16.7-76.6	1 (20.0); 0.5-71.6
	Disease control ratea	8 (72.7); 39.0-94.0	2 (40.0); 5.3-85.3
PD-L1 <1%	Objective response	n = 11	n = 16
		2 (18.2); 2.3-51.8	5 (31.2); 11.0-58.7
	Disease control ratea	4 (36.4); 10.9-69.2	11 (68.8); 41.3-89.0

Objective response and best overall response were assessed per investigator using RECIST version 1.1. Objective responses and corresponding two-sided exact 95% CIs were based on the Clopper–Pearson method by study treatment under each track.

CI, confidence interval; DCR, disease control rate; IO, immuno-oncology; IPI, ipilimumab; LAG-3, lymphocyte activation gene 3; NIVO, nivolumab; PD-L1, programmed death-ligand 1; RELA, relatlimab.

^aProportion of patients with the best overall response of complete response, partial response, or stable disease.