Table 1

Vaccine		Targeting Vaccines	Phase	Study year and Investigators	Number of Pts and Stage of Disease	Name of Antigen	Adjuvant therapy	Result
Peptide Vaccine		KRAS vaccines	I/II	Gjertsen MK, et al. [49]	5 Pts with histologically confirmed PC	Mutated K-ras		Resulted in an immune response in 2, showed longer survival
				Gjertsen MK, et al. [50] Weden S, et al.[52]	48 Pts,10 Surgically resected pts and 38 Pts with advanced disease	Mutated K-ras	GM-CSF	Peptide-specific immunity in 58% of pts. Responder’s median survival 148 vs 61 daysfor non-responders. 20% long term survivors
				Abou-Alfa GK, et al.[51]	24 Pts with resected PC	Mutated K-ras	GM-CSF	Median recurrence free survival 8.6 months; Median overall survival 20.3 months
			II	Estimated Study Completion [53]	100 Pts following resection	Mutated K-ras	Gemcitabine	Ongoing
		Gastrin vaccines		Gilliam AD, et al. [59]	154 Pts with advanced PC, unwilling or unable to take chemotherapy	Gastrin (G17DT) versus placebo		151 days G17DT vs. 82 days placebo p=0.03
		HSP-peptide complex vaccines	I	Maki RG, et al. [60]	10 Pts with resected PC	HSPCC-96		Median overall survival was 2.2 years
		WT1 vaccine		Nishida S, et. al. [61]	32 Pts with advanced pancreatic cancer	WT1	Gemcitabine	Median survival time and 1-year survival rate were 8.1 months and 29%
		cancer-testis antigens (CT) vaccine	I	Okuyama R, et al. [70]	9 Pts with advanced pancreatic cancer	CT and VEGFRs		The median overall survival (OS) was 207 days.
		VEGFRs vaccine	I/II	Gotoh M [71]	17 Unresectable, recurrent or metastatic Pts	VEGF-R1 VEGF-R2	Gemcitabine	Completed, result not reported yet
		(hTERT) vaccine	I/II	Bernhardt SL et al. [72]	48 Pts with unresectable PC	Telomerase	GM-CSF	24/38 With immune responses. Induction ofimmune response correlated with improved survival
			III	Buanes T et al. [73]	178 Pts with advanced PC	Telomerase	Gemcitabine	No overall survival benefit
			I	Crocenzi T[74]	11 Pts with Locally Advanced PC	Telomerase	tadalafil	Ongoing
		Her2/neu vaccine	I	Morse M [75]	12 Pts with Her2/neu overexpressing tumors, including PC	Her2/neu		Ongoing
		KIF20A derived vaccine	I/II	Asahara S. et al. [80]	29 Pts with Advanced PC	KIF20A		Median survival time- 142 days. Progression free survival time- 56 days.
		KIF20A derived vaccine	I	Suzuki N. et al. [81]	9 Pts with Advanced PC	KIF20A	Gemcitabine	Median survival time- 173 days
Recombinant Vaccines	MUC-1 and CEA in poxvirus	TRICOM, MUC-1 and CEA in poxvirus with GM-CSF	III	Arlen PM, et al. [79]	255 Metastatic pts following gemcitabine failure	MUC-1, CEA	TRICOM,GM-CSF	No overall survival benefit
	Listeria vaccines	Live attenuated Listeria vaccine (aNZ-100) vs Live attenuated mesothelin expressing Listeria vaccine (CrS-207)	I	Le DT, et al. [80]	28 Pts with mesothelioma, lung, pancreas, or ovarian cancer liver metastasis	Mesothelin		37% of patients in CrS-207 arm live after 15 months
	Listeria vaccines	Lethally irradiated genetically engineered allogeneic whole tumor and listeria	II	Le DT, et al. [81]	90 Pts with metastatic disease	Mesothelin and whole tumor	GM-CSF secreting allogeneic PC cells and cyclophosphamide	Ongoing
Antigen pulsed DCs vaccines		MUC-1 pulsed (DCs) vaccines	I/II	Lepisto AJ, et al. [82]	12 Pts with surgically resected pancreatic (10 pts) or biliary (2 pts) cancer	MUC-1		4 Out of 12 pts alive at 4 years
Antigen pulsed DCs vaccines		LAK cell pulsed (DCs) vaccines		Kimura Y, et al. [83]	49 Pts with unrecetable PC (Stage III,, IVa, IVB)	LAK	gemcitabine or S-1	Median overall survival of patients receiving DC vaccine and chemotherapy plus LAK cell therapy was longer than those receiving DC vaccine in combination with chemotherapy but no LAK cells
Whole tumor cell vaccines		Algenpantucel-L	II	Hardacre JM, et al. [84]	70 Pts with resected PC	whole tumor	algenpantucel-L with chemotherapy (gemcitabine and 5 FU)+ radiotherapy	12-month disease-free survival was 62 %, and the 12-month overall survival was 86 %
		Algenpantucel-L	III	Multicentered [85]	722 Pts with resected PC ( stage I,II)	whole tumor	algenpantucel-L with chemotherapy (gemcitabine and 5 FU)+ radiotherapy	Ongoing
		Allogeneic GM-CSF	I	Jaffee EM, et al. [86]	14 Pts with resected PC	whole tumor	GM-CSF vaccine with chemoradiotherapy	3 patients disease free at least 25 months after diagnosis
			II	Lutz E,et. al. [87]	60 Pts with resected PC	whole tumor	GM-CSF vaccine with chemotherapy (5FU) and radiotherapy	disease free survival of 17.3 months and an overall survival of 24.8 months
			II	Laheru DA [88]	60 Pts with resected PC	whole tumor	GM-CSF secreting allogeneic PC cells,cyclophosphamide and cetuximab	Completed, result not reported yet
			II	Laheru DA[89]	56 Pts with resected PC	whole tumor	GM-CSF secreting allogeneic PC cells	Ongoing
			II	Laheru DA [90]	87 Pts with resected PC	whole tumor	GM-CSF secreting allogeneic PC cells and IV vs oral metronomic cyclophosphamide	Ongoing
			I	Herman J[91]	18 Pts with resected PC	whole tumor	GM-CSF secreting allogeneic PC cells and cyclophosphamide followed by localized radiation (SBRT) and FOLFIRINOX	Ongoing

Pancreatic cancer-PC; 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin-FOLFIRINOX; Granulocyte-macrophage colony-stimulating factor- GM-CSF; Dendritic cell- DCs; Carcinoembryonic antigen- CEA, mucin 1-MUC-1; Lymphokine activated killer –LAK; Telomerase reverse transcriptase –hTERT; human epidermal growth factor receptor 2- Her2/neu; vascular endothelial growth factor receptors- VeGFrs; Wilms tumor gene -WT1; Heat shock protein –HSP.

Table 1: Vaccine therapy related clinical trials in pancreatic cancer.