dMMR/MSI-H population | ||
Dostarlimab (n=53) | Placebo (n=65) | |
Evaluable patients, n | 51 | 64 |
Baseline score, mean (SD) | 66.7 (25.91) | 67.3 (23.93) |
No. of patients at cycle 7 | 39 | 48 |
Change from baseline, mean (SD) | 1.4 (23.33) | −6.0 (26.12) |
Improved, n (%) | 14 (35.9) | 12 (25.0) |
Stable, n (%) | 15 (38.5) | 16 (33.3) |
Worsened, n (%) | 10 (25.6) | 20 (41.7) |
No. of patients at cycle 13 | 27 | 14 |
Change from baseline, mean (SD) | 9.2 (17.30) | −8.5 (15.86) |
Improved, n (%) | 12 (44.4) | 2 (14.3) |
Stable, n (%) | 12 (44.4) | 7 (50.0) |
Worsened, n (%) | 3 (11.1) | 5 (35.7) |
No. of patients at EOT | 22 | 43 |
Change from baseline, mean (SD) | 3.0 (19.42) | −11.1 (29.10) |
Improved, n (%) | 4 (18.2) | 9 (20.9) |
Stable, n (%) | 14 (63.6) | 13 (30.2) |
Worsened, n (%) | 4 (18.2) | 21 (48.8) |
dMMR, mismatch repair-deficient; EORTC, European Organisation for Research and Treatment of Cancer; EOT, end of treatment; MSI-H, microsatellite instability-high; QLQ-C30, Quality of Life Questionnaire Core 30; QoL, quality of life.