A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma

Table 2 Efficacy summary.

Efficacy Measure	Ipilimumab 3 mg/kg (n = 40)*	Ipilimumab 10 mg/kg (n = 42)*
Response, n (%)
CR	0	1 (2.4)
PR	3 (7.5)	4 (9.5)
SD	10 (25.0)	3 (7.1)
PD	19 (47.5)	24 (57.1)
Unknown	8 (20.0)	10 (23.8)
BORR, % (95% CI)	7.5 (1.6, 20.4)	11.9 (4.0, 25.6)
DCR, %	32.5	19.0
OS, median, in months	12.9	11.8
1-year survival rate^†, % (95% CI)	60.9 (41.7, 74.9)	44.2 (24.1, 64.1)
PFS, median (95% CI), in months	2.63 (2.56, 3.88)	2.56 (2.50, 2.66)
Progressed or died, n (%)	28 (70.0)	32 (76.2)
Time to response, median (min- max), in months	2.5 (2.1-5.3)	2.6 (2.6-3.6)

*Four patients (10.0%) in the 3 mg/kg group and five (11.9%) in the 10 mg/kg group were censored from the analyses of response-based endpoints (BORR, PFS, DCR, time to response) because of excision or resection of index lesions.
^†Estimated.
BORR: best overall response rate; CI: confidence interval; CR: complete response; DCR: disease control rate; OS: overall survival; PD: progressive disease; PFS: progression-free survival; PR: partial response; SD: stable disease.

ISSN: 1479-5876