Safety and clinical activity with an anti-PD-1 antibody JS001 in advanced melanoma or urologic cancer patients

Table 5 JS001 clinical response was evaluated per RECIST v1.1 by investigators every 8 weeks

Histology	1 mg/kg (n = 15)	3 mg/kg (n = 15)	10 mg/kg (n = 6)	Total (n = 36)	ORR, DCR
Melanoma (n = 22)	1PR, 4SD	1CR, 2PR, 2SD	0PR	1CR, 3PR, 6SD	18.2%, 45.5%
UC (n = 8)	1PR, 2SD (1uPR)	1SD	1PR	2PR, 3SD	25.0%, 67.5%
RCC (n = 6)	1SD	1PR	1PR	2PR, 1SD	33.3%, 50.0%
Total	2PR, 7SD	1CR, 3PR, 3SD	2PR	1CR, 7PR, 10SD	22.2%, 50.0%
ORR, DCR	13.3%, 60.0%	26.7%, 46.7%	33.3%, 33.3%	22.2%, 50.0%

As of July 31, 2018, among 36 enrolled subjects, 1 confirmed complete response (CR) (acral melanoma), 7 confirmed partial response (PR) (2 acral melanoma, 1 mucosal melanoma, 2 UC, and 2 RCC), and 10 confirmed stable disease (SD) (including 1 unconfirmed PR of UC) were observed, for an objective response rate (ORR) of 22.2% (95% CI, 10.1 to 39.2) and a disease control rate (DCR) of 50.0% (95% CI, 32.9 to 67.1)

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