Table 2.

Tumor response by patient cohort in the efficacy-evaluable population (N = 101) by IRC and investigator assessment based on RECIST version 1.1.

Tumor response	PSOC (n = 82)	PROC (n = 19)
IRC assessment
BOR, n (%)
CR (confirmed)	8 (9.8)	0
PR (confirmed)	45 (54.9)	6 (31.6)
SD	25 (30.5)	12 (63.2)
PD	4 (4.9)	1 (5.3)
ORR, % (95% CI)	64.6 (53.3–74.9)	31.6 (12.6–56.6)
DCR, % (95% CI)	95.1 (88.0–98.7)	94.7 (74.0–99.9)
CBR, % (95% CI)	74.4 (63.6–83.4)	52.6 (28.9–75.6)
Investigator assessment
BOR, n (%)
CR (confirmed)	5 (6.1)	0
PR (confirmed)	46 (56.1)	5 (26.3)
SD	28 (34.1)	10 (52.6)
PD	3 (3.7)	3 (15.8)
ORR, % (95% CI)	62.2 (50.8–72.7)	26.3 (9.1–51.2)
DCR, % (95% CI)	96.3 (89.7–99.2)	78.9 (54.4–93.9)
CBR, % (95% CI)	72.0 (60.9–81.3)	52.6 (28.9–75.6)

Note: ORR was based on IRC per RECIST version 1.1. Patients were considered response-evaluable if they had measurable disease at baseline and had ≥1 postbaseline tumor assessment, unless treatment had been discontinued due to clinical progression or death prior to tumor assessment.

CBR = CR + PR + SD ≥24 weeks; DCR = CR + PR + SD; ORR = CR + PR.