Table 3. Best response evaluation in efficacy analysis set.
| Patients with post-treatment tumor assessment, n | Cohort A*(N=15) | Cohort B†(N=17) | All patients(N=32) |
| CR, n (%) | 0 | 0 | 0 |
| PR, n (%)‡ | 5 (33.3) | 1 (5.9) | 6 (18.8) |
| SD, n (%) | 6 (40.0) | 4 (23.5) | 10 (31.3) |
| PD, n (%) | 4 (26.7) | 12 (70.6) | 16 (50.0) |
| ORR, n (%) (95% CI) | 5 (33.3) (26.6, 78.7) | 1 (5.9) (0.1, 28.7) | 6 (18.8) (7.2, 36.4) |
| DCR, n (%) (95% CI) | 11 (73.3) (44.9, 92.2) | 5 (29.4) (10.3, 56.0) | 16 (50.0) (31.9, 68.1) |
| mDOR, 95% CI | NR (4.1, NR) | NR (NR, NR) | NR (4.1, NR) |
| mPFS, 95% CI | 4.0 (1.4, NR) | 1.6 (1.4, 2.5) | 2.5 (1.4, 4.0) |
| mOS, 95% CI | NR (10.0, NR) | 13.6 (7.5, NR) | NR (10.0, NR) |
PD, PR, and SD represent best change from baseline.
*
Cohort A is anti-PD-1/PD-L1 treatment-naïve group.
†
Cohort B is anti-PD-1/PD-L1 treatment-failed group.
‡
In cohorts A and B, 8 (53.3%) and 1 (5.9%) patients, respectively, achieved unconfirmed PR.
CR, complete response; DCR, disease control rate; DOR, duration of response; NR, not reachedORR, objective response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease