Immune checkpoint therapy for pancreatic cancer

Table 5 Immune checkpoint inhibitors based on articles

Target molecule	Drug	Study phase	Study design	Condition	Intervention	Cohort	Enrollment	Dose	End point	Study Arm	Adverse event	Response	Survival	Ref.
CTLA-4	Ipilimumab	2	Non-randomized	PC	Palliative	Locally advanced	27	3 mg/kg	Efficacy (ORR; CR, PR)	Ipilimumab	11% Grade 3-4 irAEs (Colitis: 1, Encephalitis: 1, Hypophysitis: 1)	No RECIST-response	NA	Royal et al[23]
	(BMS-734016/MDX-010)					Metastatic						SD: delayed progression, RECIST-progressive disease (n:1)
		1	Randomized	PC	Palliative	Locally advanced	30	10 mg/kg	Safety (AE)	Ipilimumab (Arm A)	73%, 80% irAEs (Arm A, B)	SD: growth < 20% growth cut-off, 7w (n:1) , 22w (n:1) (Arm A) regression 17w (n:1), stabilization 59w (n:1), 71w (n:1) (Arm B)	mOS (95%CI:) IPI vs IPI, GVAX: 3.6 (2.5-9.2), 5.7 (4.3-14.7);	Le et al[24]
						Metastatic			Efficacy (OS, ORR)	Ipilimumab, GVAX (Arm B)	20% Grade 3-4 irAEs (Colitis: 1, GBS: 1, Nephritis: 1) (Arm A), (Rash: 1, Colitis: 1, Pneumonitis: 1) (Arm B)		HR = 0.51, 95%CI: 0.23-1.08, P = 0.072.
											irAEs (p: 0.037)		yOS (95%CI:) IPI vs IPI, GVAX: 7% (1%-45%), 27% (11%-62%)
	Tremelimumab (CP-675/CP-675,206)	1	Non-randomized	PC	Palliative	Metastatic	34	15 mg/kg	Safety (AE, DLT, MTD)	Tremelimumab DE (C6, C10, C15), Gemcitabine	Grade 3-4 irAEs (Asthenia: 1, Nausea: 1, Diarrhea: 1, Anemi: 1, Pruritus: 1, Hypertransaminasemia: 1) (C 10), (Asthenia: 3, Nausea: 2, Diarrhea:1, Anemi: 1, Neutropenia: 2, Hypertransaminasemia: 1, Thrombocytopenia:2) (C 15) SAE:11 (Dehydration-diarrhea: 1, ACS: 1, PE: 1, Hyperbilirubinemia: 1, Hematemesis: 1) (C10) (AKI: 1, GIB: 1, Hyperbilirubinemia: 2) (C15)	PR: 8w (n:2) (10.5%: 2/19)	mOS (95%CI:) C6 (6 mg/kg Tremelimumab), C10 (10 mg/kg Tremelimumab), C15 (15 mg/kg Tremelimumab): 5.3 (1.2-14.6), 8.0 (2.3-16.9), 7.5 (6.0-9.5)	Aglietta et al[27]
									Efficacy (OS, OR, PFS)			SD: > 10w [n:7 (n:2 completed study)]
PD-L1	BMS-936559	1	Non-randomized	PC, NSCLC, MM, CrC, OC, GeC, RRC, BC	Palliative	Locally advanced	207 (14 PDA)	DE	Safety (AE, MTD, DLT)	BMS-936559	NA	No objective PDA-response	NA	Brahmer et al[79]
						Metastatic			Efficacy (ORR)
									PK

PDA: Pancreatic ductal adenocarcinoma; MTD: Maximum tolerance dose; ORR: Overall response rate; DLT: Dose limiting toxicity; NA: Not available; CTLA-4: Cytotoxic T lymphocyte antigen 4; PD-L1: Programmed cell death ligand 1.