Table I.
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.