Table I.

Response outcomes.

		IC
Response	R-InO (n=166)	R-B (n=137)	R-G (n=35)	Total (n=172)
ORR,* n (%) [95% CI]	68 (41) [33–49]	66 (48) [40–57]	9 (26) [12–43]	75 (44) [36–51]
CR	21 (13)	23 (17)	0	23 (13)
unCR	5 (3)	5 (4)	0	5 (3)
PR	28 (17)	26 (19)	2 (6)	28 (16)
unPR	14 (8)	12 (9)	7 (20)	19 (11)
SD	18 (11)	7 (5)	5 (14)	12 (7)
PD	64 (39)	46 (34)	16 (46)	62 (36)
Missing†	15 (9)	17 (12)	5 (14)	22 (13)
Median (95% CI) DOR, ‡ months	11.6 (7.8–NR)	7.2 (6.5–10.8)	3.0 (0.9–NR)	6.9 (5.5–10.8)

CI=confidence interval; CR=complete response; DOR=duration of response; IC=investigator’s choice (rituximab plus bendamustine [R-B] or rituximab plus gemcitabine [R-G]); NR=not reported; ORR=objective response rate; PD=disease progression; PR=partial response; R-InO=inotuzumab plus rituximab; SD=stable disease; unCR=unconfirmed complete response; unPR=unconfirmed partial response.

^*ORR=CR+unCR+PR+unPR; difference in response between R-InO and IC arms (P=0.714 for ORR based on the Cochran-Mantel-Haenszel test).

^†1 patient in the R-InO and 1 patient in the R-B group had an indeterminate response.

^‡Confirmed and unconfirmed CR/PR; HR=0.76 (0.47–1.25); P=0.142 for difference in DOR between arms.