Table 2.
Antitumor activity
| Cohort A1 | |||
| dMMR (n=106) | MSI-H and MMRunk (n=2) | Overall (n=108) | |
| Median follow-up (IQR), months | 13.8 (9.5–22.1) | 11.1 (0.03–22.1) | 16.3 (9.5–22.1) |
| ORR, n (%, 95% CI) | 46 (43.4, 33.8 to 53.4) | 1 (50.0, 1.3 to 98.7) | 47 (43.5, 34.0 to 53.4) |
| Best confirmed response, n (%) | |||
| CR | 11 (10.4) | 0 | 11 (10.2) |
| PR | 35 (33.0) | 1 (50.0) | 36 (33.3) |
| SD | 13 (12.3) | 0 | 13 (12.0) |
| PD | 39 (36.8) | 0 | 39 (36.1) |
| NE | 8 (7.5) | 1 (50.0) | 9 (8.3) |
| DCR, n (%) | 59 (55.7) | 1 (50.0) | 60 (55.6) |
| Response ongoing | 41 of 46 (89.1%) | 1 of 1 (100%) | 42 of 47 (89.4%) |
| Median DOR | Not reached | Not reached | Not reached |
| K-M estimated probability of remaining in response, % | |||
| 6 months | 97.8 | 100 | 97.9 |
| 12 months | 90.6 | 100 | 90.9 |
| 18 months | 79.2 | 100 | 80.1 |
| Cohort A2 | |||
| MMRp (n=142) | MSS and MMRunk (n=14) | Overall (n=156) | |
| Median follow-up (IQR), months | 11.5 (11.0–25.1) | 10.4 (10.4–30.3) | 11.5 (11.0–25.1) |
| ORR, n (%, 95% CI) | 19 (13.4, 8.3 to 20.1) | 3 (21.4, 4.7 to 50.8) | 22 (14.1, 9.1 to 20.6) |
| Best confirmed response, n (%) | |||
| CR | 3 (2.1) | 0 | 3 (1.9) |
| PR | 16 (11.3) | 3 (21.4) | 19 (12.2) |
| SD | 31 (21.8) | 1 (7.1) | 32 (20.5) |
| PD | 77 (54.2) | 8 (57.1) | 85 (54.5) |
| NE | 15 (10.6) | 2 (14.3) | 17 (10.9) |
| DCR, n (%) | 50 (35.2) | 4 (28.6) | 54 (34.6) |
| Response ongoing | 12 of 19 (63.2%) | 2 of 3 (66.7%) | 14 of 22 (63.6%) |
| Median DOR | Not reached | Not reached | Not reached |
| K-M estimated probability of remaining in response, % | |||
| 6 months | 83 | 66.7 | 80.7 |
| 12 months | 61.3 | 66.7 | 62.1 |
| 18 months | 61.3 | 66.7 | 62.1 |
CR, complete response; DCR, disease control rate; dMMR, mismatch repair deficient; DOR, duration of response; K-M, Kaplan-Meier; MMRp, mismatch repair proficient; MMRunk, mismatch repair unknown; MSI-H, microsatellite instability-high; MSS, microsatellite stable; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease.