Table 3.
Summary of OS outcomes based on sTA-MUC1 baseline values
| Study phase/subgroup (patients n) | Median OS (95% CI), months | OSR at 6 months, % (95% CI) | OSR at 12 months, % (95% CI) |
|---|---|---|---|
| Primary phase (n = 20) | 11.1 (4.1-18.7) | 67.7 (41.6-84.0) | 41.4 (18.0-63.4) |
| sTA-MUC1 result at baseline <61.42 U/ml (n = 9) | 17.3 (2.6-NC) | 77.8 (36.5-93.9) | 66.7 (28.2-87.8) |
| sTA-MUC1 result at baseline ≥61.42 U/ml (n = 11) | 11.1 (2.8-11.4) | 58.3 (23.0-82.1) | 14.6 (0.8-46.6) |
| Extension phase (n = 30) | 8.0 (4.8-11.6) | 66.1 (44.7-80.9) | 27.1 (11.3-45.7) |
| sTA-MUC1 result at baseline <61.42 U/ml (n = 16) | 4.8 (2.3-8.8) | 49.4 (21.5-72.3) | 24.7 (6.1-49.7) |
| sTA-MUC1 result at baseline ≥61.42 U/ml (n = 14) | 9.3 (5.3-14.4) | 83.9 (49.4-95.7) | 28.8 (7.0-55.7) |
| mCRC with prior anti-EGFR (n = 19) | 8.0 (4.8-NC) | 68.6 (39.7-85.7) | 32.0 (10.6-56.1) |
| sTA-MUC1 result at baseline <61.42 U/ml (n = 10) | 4.8 (1.1-NC) | 47.3 (11.7-77.0) | 31.5 (4.7-64.6) |
| sTA-MUC1 result at baseline ≥61.42 U/ml (n = 9) | 8.5 (5.3-NC) | 87.5 (38.7-98.1) | 31.3 (4.8-64.1) |
CI, confidence interval; EGFR, epidermal growth factor receptor; mCRC, metastatic colorectal cancer; NC, not calculated; OS, overall survival; OSR, overall survival rate; sTA-MUC1, soluble tumor-associated epitope of mucin 1.