Table 1.
Primary endpoint analysis.
| dMMR | dMMR/MSI-H | |
|---|---|---|
| dMMR/MSI-H EC | (N = 141) | (N = 143) |
| Median follow-up, months | 27.6 | |
| ORR, n, % (95% CI) | 64, 45.4% | 65, 45.5% |
| (37.0–54.0) | (37.1–54.0) | |
| Best confirmed response, n (%) | ||
| CR | 22 (15.6) | 23 (16.1) |
| PR | 42 (29.8) | 42 (29.4) |
| SD | 21 (14.9) | 21 (14.7) |
| PD | 51 (36.2) | 51 (35.7) |
| NE | 5 (3.5) | 6 (4.2) |
| DCR, n (%) | 85 (60.3) | 86 (60.1) |
| Median DOR (95% CI), months | NR (38.9–NR) | NR (38.9–NR) |
| Duration ≥12 months, n (%) | 51 (79.7) | 52 (80.0) |
| Duration ≥24 months, n (%) | 28 (43.8) | 29 (44.6) |
| Probability of maintaining response (95% CI) | ||
| At 12 months | 93.1 (82.7–97.4) | 93.3 (83.0–97.4) |
| At 24 months | 83.4 (70.3–91.0) | 83.7 (70.8–91.2) |
| MMRp | MMRp/MSS | |
|---|---|---|
| MMRp/MSS EC | (N = 142) | (N = 156) |
| Median follow-up, months | 33.0 | |
| ORR, n, % (95% CI) | 21, 14.8% (9.4–21.7) | 24, 15.4% (10.1–22.0) |
| Best confirmed response, n (%) | ||
| CR | 4 (2.8) | 4 (2.6) |
| PR | 17 (12.0) | 20 (12.8) |
| SD | 28 (19.7) | 29 (18.6) |
| PD | 80 (56.3) | 88 (56.4) |
| NE | 13 (9.1) | 15 (9.6) |
| DCR, n (%) | 49 (34.5) | 53 (34.0) |
| Median DOR (95% CI), months | 19.4 (7.3–38.1) | 19.4 (8.2–NR) |
| Duration ≥12 months, n (%) | 10 (47.6) | 12 (50.0) |
| Duration ≥24 months, n (%) | 6 (28.6) | 8 (33.3) |
| Probability of maintaining response (95% CI) | ||
| At 12 months | 59.2 (34.7–77.2) | 60.3 (37.5–77.0) |
| At 24 months | 40.0 (17.7–61.5) | 44.2 (22.7–63.8) |
Abbreviations: CR, complete response; NE, not evaluable, includes patients with a best response of not done; NR, not reached; PD, progressive disease; PR, partial response; SD, stable disease.