Table 3.

Summary of IRC-assessed and investigator-assessed tumor response

	IRC-assessed N = 64		Investigator-assessed N = 64
	n	%	n	%
Best response by RECIST
Complete response	0	0	0	0
Partial response	33	51.6	36	56.3
Stable disease†	28	43.8	25	39.1
Progressive disease	1	1.6	1	1.6
Indeterminate‡	2	3.1	2	3.1
Objective response rate	33	51.6	36	56.3
95% CI§	—	38.7–64.2	—	43.3–68.6

^†Stable disease ≥8 weeks.

^‡No tumor assessment after dosing due to adverse event-related discontinuation.

^§Using exact method based on binomial distribution. CI, confidence interval; IRC, independent review committee; RECIST, Response Evaluation Criteria in Solid Tumors, —; not applicable.