Table 2 Efficacy of geptanolimab
Endpoint | Full analysis set | All patients enrolled | ||
|---|---|---|---|---|
Investigator assessed (n = 89) | IRRC assessed (n = 89) | Investigator assessed (n = 102) | IRRC assessed (n = 102) | |
ORR | ||||
 No. of patients | 34 | 36 | 37 | 39 |
 % of patients (95% CI) | 38.2 (28.1 to 49.1) | 40.4 (30.2 to 51.4) | 36.3 (27.0 to 46.4) | 38.2 (28.8 to 48.4) |
DCR | ||||
 No. of patients | 49 | 53 | 54 | 57 |
 % of patients (95% CI) | 55.1 (44.1 to 65.6) | 59.6 (48.6 to 69.8) | 52.9 (42.8 to 62.9) | 55.9 (45.7 to 65.7) |
Objective response, n (%) | ||||
 CR | 8 (9.0) | 13 (14.6) | 8 (7.8) | 14 (13.7) |
 PR | 26 (29.2) | 23 (25.8) | 29 (28.4) | 25 (24.5) |
 SD | 15 (16.9) | 17 (19.1) | 17 (16.7) | 18 (17.6) |
 PD | 32 (36.0) # | 28 (31.5) | 37 (36.3)& | 34 (33.3) |
 Not reported§ | 8 (9.0) | 8 (9.0) | 11 (10.8) | 11 (10.8) |
Median DOR, months | ||||
 Median (95% CI) | 4.0 (1.5 to NR) | 11.4 (4.8 to NR) | 4.2 (1.5 to NR) | 7.4 (5.1 to NR) |
 % of patients ≥ 6 months (95% CI) | 46.9 (29.1 to 62.8) | 60.5 (41.8 to 74.8) | 48.6 (31.4 to 63.7) | 60.9 (43.0 to 74.7) |
 % of patients ≥ 12 months (95% CI) | 46.9 (29.1 to 62.8) | 48.5 (29.6 to 65.0) | 40.8 (23.9 to 57.0) | 43.8 (26.3 to 60.0) |