Table 2.
Clinical outcomes
| Dose level | Median number of cycles (range) | Immune response | Individual patient PFS in months | Individual patient OS in months |
|---|---|---|---|---|
|
500 ug (n=5) |
4 (2–6) |
unknown | 1.4, 4.8, 4.9 | 7.8, 19.3, 20.6 |
| no | 4.5 | 14.9 | ||
| yes | 8.3 | 48.9 | ||
|
750 ug (n=5) |
4 (1–9) |
no | 1.1, 1.9, 3.7,15.8 | 3.4, 4.0, 7.2, 51.2+ |
| yes | 4.6 | 24.7 | ||
|
1000 ug (n=5) |
1 (1–2) |
unknown | 0.9 | 2.1 |
| no | 1.0, 1.0, 1.1, 1.8 | 6.3, 7.5, 9.9, 18.9 | ||
|
1250 ug (n=5) |
1 (1–3) |
unknown | 0.9, 0.9, 1.0 | 1.4, 3.1, 5.3 |
| no | 2.7, 2.8 | 7.6, 17.4 | ||
|
1500 ug (n=3) |
4 (3–7) |
no | 2.8 | 7.2 |
| yes | 4.2, 10.3 | 6.2, 24.0 | ||
|
1750 ug (n=5) |
2 (1–6) |
unknown | 1.0 | 18.6 |
| no | 1.1, 1.9, 2.1, 8.2 | 2.7, 3.2, 10.4, 27.2+ | ||
|
2000 ug (n=6) |
4 (1–12+) |
unknown | 0.7 | 7.2 |
| no | 1.1, 4.8, 5.6, 8.3, | 7.5, 14.1+,16.8+, 17.9+ | ||
| yes | 19.5+ | 22.2+ |
bold faced numbers indicate patients who had a 2–4 fold increase in at least one tetramer positive CTL