Immune checkpoint-targeted antibodies: a room for dose and schedule optimization?

Maritaz, Christophe; Broutin, Sophie; Chaput, Nathalie; Marabelle, Aurélien; Paci, Angelo

doi:10.1186/s13045-021-01182-3

Journal of Hematology & Oncology

Table 2 Summary of efficacy and safety end points for ICIs by indication and dosage observed in development studies

From: Immune checkpoint-targeted antibodies: a room for dose and schedule optimization?

Target	Drug	Indication	Dose	ORR (%)	PFS (% at 24 weeks; otherwise median)	OS (% at 1 year; otherwise median or specified)	G3-G4 toxicity (%)
CTLA-4	Ipilimumab [7,8,9,10,11]	Melanoma	3 mg/kg Q3W	[4.2–19]	12.9% [2.63–2.9] months	[39.3–60.9]%	[15–27.3]
			10 mg/kg Q3W	[11.1–15]	18.9% [2.56–2.8] months	[44.2–54.3]%	[31–34]
			0.3 mg/kg Q3W	0	2.7%	39.6%
		RCC	1 mg/kg Q3W	40.4	55.6%	81%	38.3
		RCC	3 mg/kg Q3W	40.4	63.8%	85%	61.7
PD-1	Nivolumab [9, 12,13,14,15,16,17,18,19]	Melanoma	0.1 mg/kg Q2W	[29–35]	[40–41]%		[0–5]
			0.3 mg/kg Q2W	[19–28]	[31–35]%		[0–3]
			1 mg/kg Q2W	[30 31]	[45–51]%		[6–12]
			3 mg/kg Q2W	[31–43.7]	[39–55]% 6.9 months	72.9%	[4–16.3]
			10 mg/kg Q2W	[9–20]	[30–45]%		[8–21]
		NSCLC	1 mg/kg Q2W	[3–6]	[26–46]%	33%	15.2
			3 mg/kg Q2W	[24–32]	[40–41]%	56%	13.5
			10 mg/kg Q2W	[18–20]	[24–33]%	38%	13.6
		RCC	0.3 mg/kg Q2W	20	30%	18.2%	5
			1 mg/kg Q2W	[24–28]	[47–50]%		12
			2 mg/kg Q2W	22	30%	25.5%	17
			10 mg/kg Q2W	31	67%	24.7%	13
		Mixed	480 mg Q4W				14.8
	Pembrolizumab [20,21,22,23,24,25,26,27,28,29,30,31]	Melanoma	2 mg/kg Q3W	[21–32.9]	45%	58%	[8–15]
			10 mg/kg Q2W	[33.7–52]			[13.3–22.8]
			10 mg/kg Q3W	[26–35.9]	37%	53%	[3.6–16]
		NSCLC	2 mg/kg Q3W	[15–25]	3.9 months	10.4 months	13
			10 mg/kg Q2W	[19.3–21]			9
			10 mg/kg Q3W	[19.2–25]	4 months	12.7 months	[3.6–16]
		Hodgkin lymphoma	10 mg/kg Q2W	65	69%	100% at 24 weeks	22
		Hodgkin lymphoma	200 mg Q3W	69			5.4
		HNSCC	10 mg/kg Q2W	18			23
		HNSCC	200 mg Q3W	16	23%	59% at 24 weeks	15
		Urothelial cancer	10 mg/kg Q2W	26	2 months	13 months	15
		Urothelial cancer	200 mg Q3W	24	2.1 months	10.3 months	15
	Cemiplimab [32]	Cutaneaous SCC	350 mg Q3W	41	10.4 months	76.1%	39.3
	Cemiplimab [32]	Cutaneaous SCC	3 mg/kg Q2W	49	18.4 months	81.3%	50.8
PD-L1	Avelumab [33,34,35,36]	RCC	10 mg/kg Q2W	[51.4–58]	13.8 months		[58–71.2]
		Merkel cell carcinoma	10 mg/kg Q2W	31.8	40%	69% at 24 weeks	5
		Mixed	1 mg/kg Q2W	0			25
			3 mg/kg Q2W	0			0
			10 mg/kg Q2W	13			33
			20 mg/kg Q2W	10			14
	Atezolizumab [37, 38]	NSCLC	1200 mg Q3W	14	2.8 months	13.8 months	13
		NSCLC	1; 3; 10; 15, 20 mg/kg Q3W	23	45%
		Melanoma		30	41%
		RCC		14	48%
		Urothelial cancer	1200 mg Q3W	15	2.1 months	7.9 months	16
	Durvalumab [39,40,41,42]	SCLC	1500 mg Q3W	68	45%	54%	22
		Urothelial cancer	10 mg/kg Q2W	31			5
		NSCLC	3 mg/kg Q2W	0			0
			10 mg/kg Q2W	33			67
			15 mg/kg Q2W	33			72
			20 mg/kg Q2W	50			61
			10 mg/kg Q2W	0	17.2 months	83.1%	[30.5–53]

ORR, Objective response rate; PFS, Progression-free survival; OS, Overall survival; G3–G4, grade3–grade4

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