TABLE 7.
Association Between Immune Response and Clinical Outcome
| Outcome* | Immune Responders† | Percent T cells at Baseline‡ Median (Range)
|
Peak percent T Cells After Immunization§ Median (Range)
|
Patients With Coinduction of T Cells at End of Cycle 2||
|
||
|---|---|---|---|---|---|---|
| PRAME | PSMA | PRAME | PSMA | PRAME & PSMA | ||
| Rapid tumor progression | 7/14 | 0.17 (0–0.62) | 0.19 (0–0.43) | 0.23 (0.08–1.54) | 0.22 (0.13–1.29) | 1/14 |
| Disease control | 6/7 | 0.07 (0–0.48) | 0.05 (0–0.44) | 0.43 (0.16–0.84) | 0.51 (0.16–1.67) | 4/7 |
Patients were categorized retrospectively in 2 clinical outcome groups: with SD for 6 months or longer (disease control), or with rapidly progressing disease.
Immune responders according to preset criteria/total number of patients in that clinical outcome group. P value of 2-tailed Fisher exact test comparing the 2 groups was 0.1736.
Percent tetramer+ CD8+ T cells in peripheral blood, at baseline.
Percent tetramer+ CD8+ T cells in peripheral blood, after immunization.
Number of patients who showed measurable immune responses against both antigens at the completion of second cycle, per total number of patients in that clinical outcome group. P value of 2-tailed Fisher exact test comparing the 2 groups was 0.0251.