Table 3.
Confirmed response per RECIST v1.1 as assessed by investigator.
| Livmoniplimab Monotherapy (Q2W) | ||||||||
|---|---|---|---|---|---|---|---|---|
| Livmoniplimab dosage | 3mg (N=1) |
10mg (N=1) |
30mg (N=3) |
100mg (N=3) |
300mg (N=3) |
1000mg (N=4) |
1500mg (N=8) |
Total (N=23) |
|
Objective response rate (CR + PR)a
N (%) 95% CIb |
0 (-, -) |
0 (-, -) |
0 (-, -) |
0 (-, -) |
0 (-, -) |
0 (-, -) |
0 (-, -) |
0 (-, -) |
|
Best overall response per RECIST v1.1c
CR PR SDd PD Not evaluable Not assessede |
0 0 0 1 (100) 0 0 |
0 0 0 1 (100) 0 0 |
0 0 0 3 (100) 0 0 |
0 0 2 (67) 1 (33) 0 0 |
0 0 2 (67) 1 (33) 0 0 |
0 0 0 3 (75) 0 1 (25) |
0 0 3 (38) 4 (50) 0 1 (13) |
0 0 7 (30) 14 (61) 0 2 (9) |
|
Duration of objective responsef
Median (months) 95% CIg |
NR (-, -) |
NR (-, -) |
NR (-, -) |
NR (-, -) |
NR (-, -) |
NR (-, -) |
NR (-, -) |
NR (-, -) |
| Livmoniplimab (Q2W) + Budigalimab (500mg Q4W) Combination Therapy | ||||||||
|---|---|---|---|---|---|---|---|---|
| Livmoniplimab dosage | 10mg (N=4) |
30mg (N=8) |
100mg (N=3) |
300mg (N=4) |
1000mg (N=4) |
1500mg (N=11) |
Total (N=34) |
|
|
Objective response rate (CR + PR)a
N (%) 95% CIb |
0 (-, -) |
2 (25) (3.2, 65.1) |
1 (33) (0.8, 90.6) |
0 (-, -) |
0 (-, -) |
2 (18) (2.3, 51.8) |
5 (15) (5.0, 31.1) |
|
|
Best overall response per RECIST v1.1c
CR PR SDd PD Not evaluable Not assessede |
0 0 3 (75) 1 (25) 0 0 |
0 2 (25) 2 (25) 4 (50) 0 0 |
0 1 (33) 0 2 (67) 0 0 |
0 0 0 3 (75) 0 1 (25) |
0 0 0 4 (100) 0 0 |
0 2 (18) 4 (36) 4 (36) 1 (9) 0 |
0 5 (15) 9 (27) 18 (53) 1 (3) 1 (3) |
|
|
Duration of objective responsef
Median (months) 95% CIg |
NR (-, -) |
7.5 (3.65, -) |
5.5 (-, -) |
NR (-, -) |
NR (-, -) |
NR (-, -) |
8.4 (3.65, -) |
|
aConfirmed objective response based on 2 consecutive response assessments at least 28 days apart. bFrom exact binomial distribution. cBased on response assessment visits prior to subsequent anticancer therapy. dBased on response assessment visit at least 35 days after first dose of study drug. ePatients discontinued study with no postbaseline response assessment (or scan), or patients recently enrolled and did not reach the first postbaseline tumor assessment time point yet and captured under “Other reason for not assessed” category. fDuration of response is defined as the time from the date of first documented CR or PR to the documented date of PD or death, whichever occurs first. Patients who neither progressed nor died or received subsequent anticancer therapy are censored at the last evaluable disease assessment. Patients with subsequent anticancer therapy are censored at the date of last tumor assessment prior to the start of the new therapy. gBased on Kaplan-Meier estimates.
CI, confidence interval; CR, complete response; NR, not reached; PD, progressive disease; PR, partial response; Q2W, once every 2 weeks; Q4W, once every 4 weeks; RECIST, Response Evaluation Criteria in Solid Tumors version 1.1; SD, stable disease.