Table 2.
Clinical activity of bintrafusp Alfa by RECIST criteria (N = 38).
| Clinical activity endpoint | Per investigator review (n = 38) | Per independent review (n = 38) |
|---|---|---|
| Confirmed BOR (CR + PR), No; % (95% CI) | 9; 23.7 (12.4–38.8) | 9; 23.7 (12.4–38.8) |
| CR, No; % (95% CI) | 2; 5.3 (1.1–15.8) | 2; 5.3 (1.1–15.8) |
| PR, No; % (95% CI) | 7; 18.4 (8.6–32.8) | 7; 18.4 (8.6–32.8) |
| SD, No; % (95% CI) | 3; 7.9 (8.6–32.8) | 4; 10.5 (3.7–23.1) |
| PD, No; % (95% CI) | 26; 68.4 (2.3–19.6) | 25; 65.8 (50–79.3) |
| DCR (CR + PR + SD ≥ 6 months), No; % (95% CI) | 12; 31.6 (18.6–47.3) | 11; 28.9 (15.4–45.9) |
| Median DOR, No; months (range) | 18.5 (1.7–21.9) | 19.2 (4.3–21.9) |
| Median TTP, No; months (range) | 2.1 (2.0–2.5) | 2.1 (1.9–2.4) |
| Median PFS (95% CI), months | 2.1 (1.8–2.4) | 2.3 (1.9–2.4) |
| 6-month PFS rate (95% CI), % | 31.6 (18.6–47.3) | 33.2 (19.8–46.5) |
| 12-month PFS rate (95% CI), % | 28.9 (16.5–44.5) | 30.1 (18.4–45.3) |
| Median OS (95% CI), months | 17.0 (13.4–20.6) | 17.0 (13.4–20.6) |
| 6-month OS rate (95% CI), % | 76.3 (61.2–87.6) | 76.3 (61.2–87.6) |
| 12-month OS rate (95% CI), % | 63.2 (47.3–77.1) | 63.2 (47.3–77.1) |
BOR, best of response; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; DCR, disease control rate; DOR, duration of response; TTP, time to progression; PFS, progression-free survival; OS, overall survival.