Table 3.
Summary of best overall response per RECIST v1.1 criteria
| Response | LHC165 SA patients n = 21 | LHC165 + spartalizumab patients n = 24 | All patients N = 45 |
|---|---|---|---|
| Best overall response, n (%) | |||
| CR | 0 | 0 | 0 |
| PR | 1 (4.8) | 2 (8.3) | 3 (6.7) |
| SD | 0 | 5 (20.8) | 5 (11.1) |
| PD | 14 (66.7) | 13 (54.2) | 27 (60.0) |
| Unknown | 6 (28.6) | 4 (16.7) | 10 (22.2) |
| ORR (CR + PR), n (%) | 1 (4.8) | 2 (8.3) | 3 (6.7) |
| 90% CIa | (0.2-20.7) | (1.5-24.0) | (1.8-16.3) |
| DCR (CR + PR + SD), n (%) | 1 (4.8) | 7 (29.2) | 8 (17.8) |
| 90% CIa | (0.2-20.7) | (14.6-47.9) | (9.2-29.8) |
| DOR (months) | |||
| n | 1 | 2 | 3 |
| Median (range) | 3.81 (3.8-3.8) | 21.74 (13.8-29.7) | 13.77 (3.8-29.7) |
CI, confidence interval; CR, complete response; DCR, disease control rate; DOR, duration of response; ORR, overall response rate; PD, progressive disease; PR, partial response; SD, stable disease.
a
The 90% CIs for ORR and DCR were computed using the Clopper–Pearson method.