Table 4.

Completed Phase III RCTs on targeted drugs for pancreatic ductal adenocarcinoma.

N	Setting	Intervention	Results	Reference
1062	Advanced PDA First-line	Arm I: Chemotherapy alone Arm II: Chemotherapy with sequential GV1001 (telomerase peptide vaccine) Arm III: Chemotherapy with concurrent GV1001	Sequential chemoimmunotherapy group OS HR = 1.19 [98.25% CI, 0.97–1.48]; p = 0.05 Concurrent chemoimmunotherapy group OS HR = 1.05 [98.25% CI, 0.85–1.29]; p = 0.64	TeloVac trial [91]
745	Locally Advanced PDA First-line	Gemcitabine + Cetuximab vs. Gemcitabine alone	OS HR = 1.06 [95% CI, 0.91–1.23]; p = 0.23, one-sided	Southwest Oncology Group-directed intergroup trial S0205 [92]
722	Adjuvant PDA	Algenpantucel-L (HAPa) Immunotherapy + SOC vs. SOC alone	Study completed No statistically significant difference on preliminary report OS 27.3 vs. 30.4 months	IMPRESS trial [93]
688	Advanced PDA First-line	Gemcitabine + Tipifarnib (R115777) vs. Gemcitabine + Placebo	OS HR = 1.03 [95% CI, 0.86–1.23]; stratified log-rank p = 0.75	[94]
632	Advanced PDA First-line	Gemcitabine + AG-013736 (Axitinib) vs. Gemcitabine + Placebo	OS HR = 1.014 [95% CI, 0.786–1.309]; p = 0.5436	[95]
602	Advanced PDA First-line	Gemcitabine + Bevacizumab vs. Gemcitabine plus Placebo	OS HR = 1.044 [95% CI, 0.88 to 1.24]; p = 0.95	CALGB 80303 trial [96]
160 *	Metastatic PDA First-line	Rigosertib (ON 01910.Na) + Gemcitabine vs. Gemcitabine alone	OS HR = 1.24 [95% CI, 0.85–1.81]	[97]
154	Advanced PDA First-line	G17DT immunogen vs. Placebo	Mortality HR = 0.75 [95% CI, 0.51–1.10]; p = 0.138	[98]
153 *	Advanced PDA First-line	Elpamotide + Gemcitabine vs. Placebo + Gemcitabine	OS HR = 0.87 [95% CI, 0.486–1.557]; Harrington-Fleming p-value = 0.918; log-rank p-value = 0.897	[99]

Hazard ratio (HR); overall survival (OS); pancreatic ductal adenocarcinoma (PDA); * Phase 2/3 RCT.