Clinical activity of bintrafusp alfa (N=32)
| Clinical activity endpoint | Per IRC assessment | Per investigator assessment |
| Confirmed BOR, n (%) | ||
| CR | 0 | 0 |
| PR | 4 (13) | 5 (16) |
| SD | 4 (13) | 6 (19) |
| Non-CR/non-PD* | 3 (9) | – |
| PD | 19 (59) | 18 (56) |
| Not evaluable | 2 (6)† | 3 (9)‡ |
| Confirmed ORR (95% CI), % | 13 (4 to 29) | 16 (5 to 33) |
| Total clinical response rate (95% CI), %§ | 16 (5.3 to 32.8) | 22 (9.3 to 40) |
| DCR (95% CI), % | 34 (19 to 53) | 34 (19 to 53) |
| Median PFS (95% CI), months | 1.4 (1.3 to 4.0) | 1.4 (1.3 to 3.9) |
| PFS rate (95% CI), % | ||
| 6-month | 28 (14 to 45) | 21 (9 to 37) |
| 12-month | 21 (9 to 37) | 17 (6 to 33) |
| 18-month | 21 (9 to 37) | 17 (6 to 33) |
*Persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.
†No IRC review due to no postbaseline assessments.
‡No postbaseline assessments due to death within 6 weeks after start date; no postbaseline assessments; SD (or better) of insufficient duration (<6 weeks after start date without further evaluable tumor assessment) (n=1 each).
§Defined as the proportion of patients with CR, PR and delayed PR after initial PD.
BOR, best overall response; CR, complete response; DCR, disease control rate; IRC, independent review committee; NE, not estimable; ORR, objective response rate; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease.