Table 4.
Investigator-Assessed Efficacy According to RECIST 1.1
| Characteristic, n (%) | Cohort A (n = 40) | Cohort B (n = 9) | Cohort C (n = 9) | Cohort D (n = 12) | Cohorts A+B+C (n = 58) |
|---|---|---|---|---|---|
| Confirmed BOR, n (%) | |||||
| Complete response | 0 | 1 (11.1) | 1 (11.1) | 0 | 2 (3.4) |
| Partial response | 18 (45.0) | 5 (55.6) | 3 (33.3) | 2 (16.7) | 26 (44.8) |
| Stable disease | 9 (22.5) | 0 | 3 (33.3) | 4 (33.3) | 12 (20.7) |
| Progressive disease | 7 (17.5) | 3 (33.3) | 2 (22.2) | 5 (41.7) | 12 (20.7) |
| Not evaluable | 6 (15.0) | 0 | 0 | 1 (8.3) | 6 (10.3) |
| ORR (CR + PR), n (%) | 18 (45.0) | 6 (66.7) | 4 (44.4) | 2 (16.7) | 28 (48.3) |
| DCR,a n (%) | 27 (67.5) | 6 (66.7) | 7 (77.8) | 6 (50.0) | 40 (69.0) |
| Median OSb (95% CI), mo | 11.4 (6.4–15.1) | 11.8 (1.9–NE) | NE (5.7–NE) | 16.5 (3.0–NE) | 12.5 (9.4–15.1) |
| Median PFSb (95% CI), mo | 5.0 (3.4–6.4) | 4.1 (1.2–NE) | 5.4 (1.4–NE) | 2.6 (1.5–5.9) | 5.0 (4.0–6.4) |
| Median DORb (range), mo | 9.6 (3.7–NE) | NE (2.8–NE) | 10.5 (2.8–NE) | 3.4 (3.0–3.8) | 9.6 (4.2–NE) |
BOR, best overall response; CI, confidence interval; CR, complete response; DCR, disease control rate; DOR, duration of response; NE, not estimable; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors.
a
Confirmed best overall response of complete response, partial response, or stable disease.
b
Product limit (Kaplan–Meier) estimates.