Table 2.
Summary of PFS outcomes based on sTA-MUC1 baseline values
| Study phase/subgroup (patients n) | Median PFS (95% CI), months | PFSR at 3 months, % (95% CI) | PFSR at 6 months, % (95% CI) |
|---|---|---|---|
| Primary phase (n = 20) | 2.0 (1.7-3.2) | 30.0 (12.3-50.1) | 15.0 (3.7-33.5) |
| sTA-MUC1 result at baseline <61.42 U/ml (n = 9) | 1.8 (1.3-9.2) | 33.3 (7.8-62.3) | 22.2 (3.4-51.3) |
| sTA-MUC1 result at baseline ≥61.42 U/ml (n = 11) | 2.0 (1.4-3.2) | 27.3 (6.5-53.9) | 9.1 (0.5-33.3) |
| Extension phase (n = 30) | 2.8 (1.8-5.5) | 49.8 (31.0-66.0) | 28.0 (13.2-45.0) |
| sTA-MUC1 result at baseline <61.42 U/ml (n = 16) | 1.9 (1.4-3.7) | 37.5 (15.4-59.8) | 15.0 (2.6-37.4) |
| sTA-MUC1 result at baseline ≥61.42 U/ml (n = 14) | 5.4 (1.8-7.0) | 64.3 (34.3-83.3) | 41.7 (16.4-65.4) |
| mCRC with prior anti-EGFR (n = 19) | 1.9 (1.8-5.5) | 47.4 (24.4-67.3) | 25.3 (8.6-46.2) |
| sTA-MUC1 result at baseline <61.42 U/ml (n = 10) | 1.8 (0.5-3.7) | 30.0 (7.1-57.8) | 10.0 (0.6-35.8) |
| sTA-MUC1 result at baseline ≥61.42 U/ml (n = 9) | 5.5 (1.4-7.6) | 66.7 (28.2-87.8) | 41.7 (10.9-70.8) |
CI, confidence interval; EGFR, epidermal growth factor; mCRC, metastatic colorectal cancer; PFS, progression-free survival; PFSR, progression-free survival rate; sTA-MUC1, soluble tumor-associated epitope of mucin 1.