Table 2.

Summary of responses (8 mg tilsotolimod + ipilimumab population)

Characteristic	Primary efficacy analysisa (n = 21)	Ipilimumab exposedb (n = 7)	Ipilimumab naivec (n = 42)	Totald (N = 49)
BOR, n (%)e
CR	2 (9.5)	0 (0.0)	2 (4.8)	2 (4.1)
PR	4 (19.0)	2 (28.6)	7 (16.7)	9 (18.4)
SD	10 (47.6)	2 (28.6)	22 (52.4)	24 (49.0)
PD	5 (23.8)	3 (42.9)	11 (26.2)	14 (28.6)
ORR, %f	28.6g	28.6	21.4	22.4
95% CI, %	11.3-52.2	ND	10.3-36.8	11.8-36.6
DCR, %h	76.2	57.1	73.8	71.4
95% CI, %	52.8-91.8	ND	58.0-86.1	56.7-83.4
Median DOR, mo	ND	ND	11.4	11.4
Interquartile range			10.2-NE	4.2-NE

Abbreviations: BOR, best overall response; CI, confidence interval; DOR, duration of response; ND, not determined; NE, not estimable; PD, progressive disease.

^aThe primary efficacy analysis was ORR assessed in the first 21 patients who did not receive ipilimumab for metastatic disease enrolled at the RP2D of tilsotolimod in combination with ipilimumab.

^bIn the metastatic disease setting.

^cAll patients who had not received ipilimumab for metastatic disease on study entry and treated at the RP2D of tilsotolimod in combination with ipilimumab.

^dAll patients treated at the RP2D of tilsotolimod in combination with ipilimumab.

^eAssessed using RECIST v1.1.

^f(CR + PR)/number of patients × 100.

^gP = 0.02 versus ORR for historical control of 11% (20).

^h(CR + PR + SD)/number of patients × 100.