Table 3. Evaluation of immune response and clinical outcome after therapeutic cancer vaccines by log-rank test using the Kaplan-Meier model.

Product	Cancer	Phase	Evaluation results	Positive Correlation	Reference
Provenge®	Prostate cancer	P I/II	TTP correlated with development of an immune response to prostatic acid phosphatase (PAP) and with the dose of dendritic cells received.	Y	29
		P III (IMPACT)	An antibody titer of more than 400 against PA2024 or PAP after baseline lived longer than did those who had an antibody titer of 400 or less (p < 0.001 and p = 0.08, respectively). No survival difference could be detected between patients in the sipuleucel-T group who had T-cell proliferation response to PA2024 or PAP and those who did not.	Y	10
Canvaxin®	Melanoma (Stage IV)	P II	5-y OS rate was 75% for patients who had an elevated level of anti-TA90 IgM and a strong DTH response, 36% for patients who had either an elevated IgM response or a strong DTH response, and only 8% if neither response was strong (p < 0.001)	Y	30
	Melanoma (Stage II)	P II	Anti-TA90 IgM levels ≧ 1:800 were significantly correlated with improved 5-y DFS and improved 5-y OS.	Y	30
	Melanoma (Stage IIIa and IV)	After P II	Survival correlated significantly with delayed cutaneous hypersensitiity (p = 0.0066) and antibody response (p = 0.0117).	Y	31
SpecifidTM	Non-Hodgkin's lymphoma	P II (after rituximab)	There was no correlation observed between the development of anti-Id immune response and the achievement of an objective response or duration of EFS.	N	33
BEC2	Small cell lung cancer	P III	The survival of responders was better than that of non-responders, although this did not reach statistical significance (median survival, 19.2 v 13.9 mo for responders v non-responders; p = 0.0851).	Y	21
InsegiaTM	Pancreatic cancer	P II	Median survival was 217 d for the antibody responders and 121 d for the antibody non-responders. The difference in survival between the antibody responders and non-responders was significant (p = 0.0023).	Y	35
		P III (single agent)	Patients developing anti-G17DT responses (73.8%) survived longer than non-responders or those on placebo (median survival, 176 v 63 v 83 d; log-rank test, p = 0.003).	Y	40
M-VaxTM	Melanoma (Stage III)	Before P III	The development of a positive DTH response to unmodified autologous melanoma cells was associated with significantly longer 5-y survival (71% v 49%; p = 0.031).	Y	36
		P III	OS after relapse was significantly longer in patients who developed positive DTH to unmodified tumor cells (25.2% v 12.3%; p < 0.001).	Y	13
MyVax®	Non-Hodgkin's lymphoma	Before P III	Patients who mounted humoral immune responses had a longer PFS than those who did not (8.21 v 3.38 y; p = 0.018).	Y	37
Theratope®	Breast cancer	P II	51 patients who generated titers higher than median value for anti-STn+ mucin IgG survived longer than 46 patients who generated lower titers below the median.	Y	38