Table 2. Efficacy Results by Tumor Type for Patients With dMMR and MSI-H or POLE-Altered Tumors in the Efficacy Population.
| Tumor type | Patients, No. | No. (%) | ORR, % (95% CI) | mDOR (95% CI), mo | mPFS (95% CI), mo | mOS (95% CI), mo | |
|---|---|---|---|---|---|---|---|
| CR | PR | ||||||
| Overall | 347 | 46 (13.3) | 107 (30.8) | 44.1 (38.8-49.5) | NR (NR-NR) | 7.0 (4.2-13.8) | NR (39.9-NR) |
| dMMR overall | 327 | 43 (13.1) | 101 (30.9) | 44.0 (38.6-49.6) | NR (NR-NR) | 6.9 (4.2-13.6) | NR (31.6-NR) |
| EC | 143 | 23 (16.1) | 42 (29.4) | 45.5 (37.1-54.0) | NR (38.9-NR) | 6.0 (4.1-18.0) | NR (25.7-NR) |
| Non-EC | 204 | 23 (11.3) | 65 (31.9) | 43.1 (36.2-50.2) | NR (NR-NR) | 7.1 (3.6-19.5) | NR (31.5-NR) |
| Colorectal cancer | 115 | 14 (12.2) | 36 (31.3) | 43.5 (34.3-53.0) | NR (NR-NR) | 8.4 (3.4-NR) | NR (NR-NR) |
| Gastric cancer | 22 | 1 (4.5) | 9 (40.9) | 45.5 (24.4-67.8) | NR (17.5-NR) | 5.5 (2.8-NR) | 20.1 (6.7-NR) |
| Small-intestinal cancer | 23 | 5 (21.7) | 4 (17.4) | 39.1 (19.7-61.5) | NR (8.3-NR) | 8.1 (2.5-16.5) | 31.6 (8.2-NR) |
| Pancreatic carcinoma | 12 | 0 | 5 (41.7) | 41.7 (15.2-72.3) | NR (NR-NR) | 3.3 (2.6-NR) | 12.7 (3.1-NR) |
| Ovarian cancer | 7 | 0 | 3 (42.9) | 42.9 (9.9-81.6) | NAa | NAa | NAa |
| Otherb | 25 | 3 (12.0) | 8 (32.0) | 44.0 (24.4-65.1) | 4.5 (2.5-NR) | NR (8.8-NR) | NR (13.5-NR) |
Abbreviations: CR, complete response; dMMR, mismatch repair deficient; EC, endometrial cancer; mDOR, median duration of response; mOS, median overall survival; mPFS, median progression-free survival; NA, not applicable; NR, not reached; ORR, objective response rate; POLE, polymerase epsilon; PR, partial response.
mDOR, mPFS, and mOS, all with 95% CIs, could not be calculated for the ovarian cancer subgroup because of the small size of the population. However, mDOR was not reached, with a range of 6.0 or greater to 36.4 or greater months.
Other includes adrenal cortical carcinoma, biliary neoplasm, brain cancer, breast cancer, cancer of unknown primary, esophageal cancer, malignant neoplasm of the female genitals, mesothelioma, prostate cancer, renal cell carcinoma, sarcoma, and thymic tumor.