Table 2.
Responses by tumor response assessment criteria and by disease cohort
| irRC by investigator assessment | RECIST v1.1 by investigator assessment | ||||
|---|---|---|---|---|---|
| Outcome | Cervical (n = 18) | Endometrial (n = 25) | Outcome | Cervical (n = 18) | Endometrial (n = 25) |
| irORR | 2a (11.1 [2.0–31.0]) | 3a (12.0 [3.4–28.2]) | ORR | 3a (16.7 [4.7–37.7]) | 3a (12.0 [3.4–28.2]) |
| irCR | 1 (5.6 [0.3–23.8]) | 0 (0 [0–11.3]) | CR | 1 (5.6 [0.3–23.8]) | 0 (0 [0–11.3]) |
| irPR | 1 (5.6 [0.3–23.8]) | 3 (12.0 [3.4–28.2]) | PR | 2 (11.1 [2.0–31.0]) | 3 (12.0 [3.4–28.2]) |
| irSD | 2 (11.1 [2.0–31.0]) | 0 (0 [0–11.3]) | SD | 1 (5.6 [0.3–23.8]) | 0 (0 [0–11.3]) |
| irPD | 14 (77.8 [56.1–92.0]) | 21 (84.0 [67.0–94.3]) | PD | 14 (77.8 [56.1–92.0]) | 21 (84.0 [67.0–94.3]) |
| NE | 0 (0 [0–15.3]) | 1 (4.0 [0.2–17.6]) | NE | 0 (0 [0–15.3]) | 1 (4.0 [0.2–17.6]) |
| irDCR | 4 (22.2 [8.0–43.9]) | 3 (12.0 [3.4–28.2]) | DCR | 4 (22.2 [8.0–43.9]) | 3 (12.0 [3.4–28.2]) |
| – | –b | –b | BORR | 4c (22.2 [8.0–43.9]) | 3a (12.0 [3.4–28.2]) |
| irDOR (months), median (95% CI) | 16.5 + (2.9–16.5 + [NR]) | 9.0 + (8.2–9.0 + [NR]) | DOR (months), median (95% CI) | 16.5 + (2.9–16.5 + [NR]) | 8.7 + (not estimable–8.7 + [NR]) |
Data are number of patients (% [90% CI]), unless otherwise indicated. aConfirmed responses. bCompared to the patients achieving a response per immune-related response criteria (irRC) at week 26, one additional endometrial cancer patient (case ID 2) and two cervical cancer patients (case IDs 16 and 17) had a partial response per irRC at any point during the study period, although none of these three were confirmed (data not shown in Table because this was not a prespecified endpoint). cOne response (case ID 16) was not confirmed
BORR best overall response rate, CR complete response, DCR disease control rate (CR + PR + SD), DOR duration of response, irRC immune-related response criteria, NE not evaluable, NR not reached, ORR objective response rate, PD progressive disease, PR partial response, RECIST v1.1 Response Evaluation Criteria in Solid Tumors version 1.1, SD stable disease, + median value was not reached (upper bound corresponds to the longest observed value)