Table 2. Methods of immune response and clinical outcome evaluation for therapeutic cancer vaccines.
| Response |
Humoral immune response |
Cellular immune response |
Clinical outcome | Reference | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample |
Peripheral blood lymphocytes |
Skin |
Tumor lesion |
||||||||
| Product | Cancer | Phase | ELISA | ELISPOT | T cell proliferation assay | Intracellular cytokine staining | Flow cytometry | DTH testing | Pathologic assessment | ||
| Provenge® |
Prostate cancer |
P I/II |
Y |
Y |
Y |
|
|
|
|
TTP |
29
|
| P III (IMPACT) |
Y |
|
Y |
|
|
|
|
OS |
10
|
||
| Canvaxin® |
Melanoma (Stage IV) |
P II |
Y |
|
|
|
|
Y |
|
OS |
30
|
| Melanoma (Stage II) |
P II |
Y |
|
|
|
|
|
|
DFS |
30
|
|
| Melanoma (Stage IIIa, IV) |
After P II |
Y |
|
|
|
|
Y |
Y |
OS |
31
|
|
| SpecifidTM |
Non-Hodgkin's lymphoma |
P II |
Y |
|
|
Y |
|
|
|
OR |
32
|
| P II (after rituximab) |
Y |
|
|
Y |
|
|
|
OR, EFS |
33
|
||
| BEC2 |
Small cell lung cancer |
P III |
Y |
|
|
|
|
|
|
OS |
21
|
| During P III |
Y |
|
|
|
|
|
|
OS, RFS |
34
|
||
| InsegiaTM |
Pancreatic cancer |
P II |
Y |
|
|
|
|
|
|
OS |
35
|
| P III (single agent) |
Y |
|
|
|
|
|
|
OS |
22
|
||
| M-VaxTM |
Melanoma (Stage III) |
Before P III |
|
|
|
|
|
Y |
|
OS |
36
|
| P III |
|
|
|
|
|
Y |
|
OS |
13
|
||
| MyVax® |
Non-Hodgkin's lymphoma |
Before P III |
Y |
|
Y |
|
|
|
|
PFS |
37
|
| Theratope® |
Breast cancer |
P II |
Y |
|
|
|
Y |
|
|
OS |
38
|
| Total trials | 13 | 1 | 3 | 2 | 1 | 4 | 1 | ||||
Abbreviations: OS, overall survival; TTP, time to progression; DFS, disease free survival; EFS, event free survival; RFS, recurrence free survival; PFS, progression free survival; OR, objective response