Table 2.

Antitumor activity assessed by sites investigators per RECIST V.1.1

Antitumor activity	Total
	N=58
ORR, n (%) (95% CI) *	16 (27.6) (16.7 to 40.9)
DCR, n (%) (95% CI) *	35 (60.3) (46.6 to 73.0)
Best overall response, n (%)
Complete response	0 (0.0)
Partial response	16 (27.6)
Stable disease	19 (32.8)
Progressive disease	18 (31.0)
Not evaluable	5 (8.6)
Time to response† months, median (range)	1.4 (1.3–7.8)
Duration of response†‡ months, median (range)	8.0 (1.5–12.5)
PFS‡, months, median (95% CI)	4.2 (2.2 to 5.5)
6-month rate (95% CI)	28.3 (16.5 to 41.3)
OS‡, months, median (95% CI)	NR (8.7 to NR)
12 month rate (95% CI)	64.2 (49.4 to 75.7)

*Based on the Clopper-Pearson exact method.

†Evaluated in patients who had a complete or partial response.

‡Estimated using the Kaplan-Meier method.

DCR, disease control rate; NR, not reached; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; RECIST, Response Evaluation Criteria In Solid Tumors.