Table 2 Clinical efficacy evaluated by independent review committee (IRC) and investigator per RECIST v1.1 or iRECIST
| Â | IRC | Investigator | ||
|---|---|---|---|---|
N | 119 | 119 | ||
| Â | RECIST | iRECIST | RECIST | iRECIST |
CR/iCR, n (%) | 1 (0.84) | 3 (2.52) | 2 (1.86) | 2 (1.68) |
PR/iPR, n (%) | 23 (19.33) | 23 (19.33) | 22 (18.49) | 25 (21.01) |
SD/iSD, n (%) | 28 (23.53) | 31 (26.05) | 27 (22.69) | 28 (23.53) |
PD/iuPD/icPD, n (%) | 57 (47.90) | 52 (43.7) | 58 (48.74) | 54 (45.4) |
NE, n (%) | 10 (8.4) | 10 (8.4) | 10 (8.4) | 10 (8.4) |
ORR, n (%) | 24 (20.17) | 26 (21.85) | 24 (20.17) | 27 (22.69) |
95% CI | 13.370–28.506 | 14.796–30.352 | 13.370–28.506 | 15.516–31.268 |
DCR, n (%) | 52 (43.70) | 57 (47.90) | 51 (42.86) | 55 (46.22) |
95% CI | 34.625–53.091 | 38.658–57.248 | 33.827–52.252 | 37.037–55.592 |
Median PFS, months (95% CI) | 2.89 (2.037–4.074) | 4.01 (2.201–4.665) | 2.46 (2.004–4.008) | 3.98 (2.333–6.012) |
cutaneous | 4.205 (2.037–13.142) | _ | _ | _ |
acral | 3.285 (2.004–4.107) | _ | _ | _ |
mucosal | 1.971 (1.873–2.661) | _ | _ | _ |
Median DOR, months (95% CI) | NR (9.791, NR) | NR (17.577, NR) | NR (15.869, NR) | NR (15.869, NR) |
12-month DOR rate, % (95% CI) | 68.46 (42.36–84.60) | 80.36 (55.64–92.17) | 81.99 (58.83–92.83) | 83.27 (61.29–93.38) |
Median OS, months (95% CI) | 16.59 (13.963–26.973) | |||
cutaneous | NR | |||
acral | 20.107 (14.193–27.039) | |||
mucosal | 9.363 (5.092–22.505) | |||