Table 3.
Summary of AESIs
| Patients With AESI of Any Grade, n (%) | Cohort A (n = 40) | Cohort B (n = 9) | Cohort C (n = 9) | Cohort D (n = 12) | Cohorts A+B+C (n = 58) |
|---|---|---|---|---|---|
| Any AESI | |||||
| Infusion-related reaction | 5 (12.5) | 1 (11.1) | 1 (11.1) | 1 (8.3) | 7 (12.1) |
| Immune-related AE | 19 (47.5) | 3 (33.3) | 5 (55.6) | 6 (50.0) | 27 (46.6) |
| TGF-β inhibition-mediated skin AE | 6 (15.0) | 1 (11.1) | 4 (44.4) | 1 (8.3) | 11 (19.0) |
| Keratoacanthoma | 2 (5.0) | 1 (11.1) | 4 (44.4) | 1 (8.3) | 7 (12.1) |
| Squamous cell carcinoma of skin | 2 (5.0) | 0 | 0 | 0 | 2 (3.4) |
| Hyperkeratosis | 3 (7.5) | 0 | 1 (11.1) | 0 | 4 (6.9) |
| Actinic keratosis | 1 (2.5) | 0 | 0 | 0 | 1 (1.7) |
| Basal cell carcinoma | 1 (2.5) | 0 | 0 | 0 | 1 (1.7) |
| Lip squamous cell carcinoma | 0 | 0 | 0 | 0 | 0 |
| Bowen’s disease | 0 | 0 | 0 | 0 | 0 |
| Treatment-emergent anemia | 20 (50.0) | 6 (66.7) | 9 (100.0) | 9 (75.0) | 35 (60.3) |
| Any bintrafusp alfa-related TEAE of special interest | |||||
| Infusion-related reaction | 4 (10.0) | 0 | 0 | 1 (8.3) | 4 (6.9) |
| Immune-related AE | 18 (45.0) | 1 (11.1) | 4 (44.4) | 6 (50.0) | 23 (39.7) |
| TGF-β inhibition-mediated skin AE | 5 (12.5) | 1 (11.1) | 4 (44.4) | 1 (8.3) | 10 (17.2) |
| Treatment-emergent anemia | 6 (15.0) | 4 (44.4) | 2 (22.2) | 2 (16.7) | 12 (20.7) |
| Any treatment-emergent bleeding event | 19 (47.5) | 5 (55.6) | 8 (88.9) | 8 (66.7) | 32 (55.2) |
| Any treatment-emergent bintrafusp alfa-related bleeding event | 4 (10.0) | 2 (22.2) | 3 (33.3) | 1 (8.3) | 9 (15.5) |
AE, adverse event; AESI, adverse event of special interest; TEAE, treatment-emergent adverse events; TGF-β, transforming growth factor beta.