Targeting LAG-3, TIM-3, and TIGIT for cancer immunotherapy

Cai, Letong; Li, Yuchen; Tan, Jiaxiong; Xu, Ling; Li, Yangqiu

doi:10.1186/s13045-023-01499-1

Journal of Hematology & Oncology

Table 3 Anti-LAG-3 mAbs and associated clinical trials in cancer

From: Targeting LAG-3, TIM-3, and TIGIT for cancer immunotherapy

Clinical trial identifier	Phase	Start date	Status	Cancer type (population, N)	Interventions and Combination	Target	Primary Outcome Measures	Secondary Outcome Measures
NCT0206176	I/II	Mar 13, 2014	Completed	HMs, N = 106	Relatlimab	LAG-3	AEs, SAEs	Cmax, Tmax
NCT02720068	I	May 2, 2016	Active, not recruiting	Neoplasms, N = 576	Favezelimab	LAG-3	DLTs, AEs	ORR
NCT03005782	I	Nov 7, 2016	Active, not recruiting	Malignancies, N = 333	REGN3767	LAG-3	Cmax, Tmax	RECIST
NCT04566978	I	Sep 11, 2020	Recruiting	DLBCL, N = 20	89Zr-DFO-REGN3767	LAG-3	Biodistribution	–
NCT03489369	I	May 8, 2018	Completed	Metastatic Cancer Solid Tumor Lymphoma, N = 15	Sym022	LAG-3	AEs	OR, SD, TTP
NCT02195349	I	Jul 30, 2014	Completed	Psoriasis, N = 67	GSK2831781	LAG-3	PCI, AEs, SAEs	PASI, PGA
NCT02460224	I/II	Jun 17, 2015	Completed	Advanced Solid Tumor, N = 490	LAG525	LAG-3	DLTs, ORR	AEs, RDI
NCT03250832	I	Aug 8, 2017	Completed	Neoplasms, N = 111	TSR-033	LAG-3	SAEs, TEAEs	AUC, Cmax
NCT03538028	I	Jun 18, 2018	Completed	MSI-High Endometrial Cancer, CCA, GC, N = 22	INCAGN02385	LAG-3	TEAEs	Cmax, Tmax, ORR
NCT02935634	II	Nov 29, 2016	Completed	AGC, N = 190	Relatlimab + Nivolumab	LAG-3 PD-1	ORR, DOR	AEs
NCT02488759	I/II	Oct 13, 2015	Completed	Various Advanced Cancers, N = 578			AEs, ORR	DOR, OS
NCT02996110	II	Feb 2, 2017	Completed	Advanced Cancer, N = 182			ORR, DOR	AEs
NCT02519322	II	Feb 2, 2016	Completed	CM, MM, OM, N = 53				OS
NCT02061761	I/II	Mar 13, 2014	Completed	HMs, N = 106			AEs	Cmax, Tmax
NCT03310619	I/II	Nov 28, 2017	Completed	NHL, DLBCL, FL, N = 62	JCAR017 + Relatlimab	LAG-3 CD19	DLTs	AEs, PFS
NCT04112498	I	Oct 1, 2019	Completed	Cancer, N = 24	Relatlimab + rHuPH20 + Nivolumab	LAG-3 CD38 PD-1	Cmax, SAEs	AEs
NCT04626518	II	Dec 17, 2020	Recruiting	ccRCC, N = 370	Favezelimab + Pembrolizumab	LAG-3 PD-1	DLTs, AEs	DOR, PFS
NCT05342636	I/II	Jul 27, 2022	Recruiting	ESCC, N = 120			DLTs, AEs	PFS, DOR
NCT04938817	I/II	Aug 19, 2021	Active, not recruiting	SCLC, N = 80			AEs, ORR	PFS, DOR
NCT02625961	II	Feb 10, 2016	Recruiting	BC, N = 320			DFS	DOR
NCT05845814	I/II	Jul 10, 2023	Recruiting	mUC, UN, N = 390			ORR, AEs	PFS, DOR
NCT03516981	II	Oct 1, 2018	Active, not recruiting	Advanced NSCLC, N = 318			ORR	PFS, OS
NCT02720068	I	May 2, 2016	Active, not recruiting	Neoplasms, N = 576			DLTs, AEs	ORR
NCT03598608	I/II	Oct 17, 2018	Recruiting	NHL, DLBCL, N = 174			DLTs, AEs	ORR
NCT05508867	III	Oct 18, 2022	Recruiting	NHL, N = 360			PFS	OS, ORR
NCT05064059	III	Nov 10, 2021	Active, not recruiting	CRC, N = 432			OS	PFS, ORR
NCT05600309	III	Jun 14, 2022	Recruiting	CRC, N = 94			OS	PFS, ORR
NCT05137054	I	Aug 17, 2022	Recruiting	MM, N = 317	REGN3767 + Linvoseltamab	LAG-3 BCMA CD3	DLTs, TEAEs	ORR, DOR
NCT01042379	II	Mar 1, 2010	Recruiting	BC, N = 5000	REGN3767 + Cemiplimab	LAG-3 PD-1	pCR	RCB, RFS
NCT03916627	II	Jul 23, 2019	Recruiting	NSCLC, HCC, HNSCC Carcinoma, N = 73CLC			MPR, STN	ORR, OS
NCT05785767	II/III	Jun 16, 2023	Recruiting	Advanced NSCLC, N = 850			ORR, OS	TEAEs, SAEs
NCT05352672	III	Jul 14, 2022	Recruiting	Melanoma, N = 1590			PFS	OS, DCR
NCT03005782	I	Nov 7, 2016	Active, not recruiting	Malignancies, N = 333			AUC, CL	ORR
NCT03311412	I	Nov 20, 2017	Completed	Metastatic Cancer, Solid Tumor, Lymphoma, N = 89	Sym022 + Sym021 + Sym023	LAG-3 PD-1 Tim-3	AEs	OR, SD
NCT04641871	I	Oct 12, 2020	Active, not recruiting	Metastatic Cancer, Solid Tumor, N = 148	Sym022 + Sym021	LAG-3 PD-1	ORR, SAEs	Cmax, AUC
NCT03484923	II	Sep 10, 2018	Completed	Melanoma, N = 196	LAG525 + Spartalizumab	LAG-3 PD-1	ORR	OS, PFS
NCT03499899	II	Jul 2, 2018	Completed	TNBC, N = 88	LAG525 + PDR001 + Carboplatin	LAG-3 PD-1	ORR	CBR, DOR
NCT02460224	I/II	Jun 17, 2015	Completed	Advanced Solid Tumors, N = 490	LAG525 + PDR001	LAG-3 PD-1	DLTs, ORR	AEs, Cmax
NCT03365791	II	Jan 24, 2018	Completed	SCLC, GAC, EAC, CRPC Adenocarcinoma, N = 76	LAG525 + PDR001	LAG-3 PD-1	CBR	ORR, TTR
NCT03250832	I	Aug 8, 2017	Completed	Neoplasms, N = 111	TSR-033 + Dostarlimab + mFOLFOX6 + FOLFIRI + Bevacizumab	LAG-3 PD-1 VEGF-A	SAEs, TEAEs	AUC, Cmax
NCT04463771	II	Jan 26, 2021	Recruiting	UCEC, N = 300	INCAGN02385 + INCMGA00012	LAG-3 PD-1	ORR	CR, OS
NCT04370704	I/II	Jul 27, 2020	Recruiting	Melanoma, N = 146	INCAGN02385 + INCAGN02390 + INCMGA00012	LAG-3 PD-1 Tim-3	TEAEs, ORR	DCR
NCT05287113	II	Nov 14, 2022	Recruiting	HNSC, N = 162	INCAGN02385 + Retifanlimab	LAG-3 PD-1	PFS	ORR, DOR, etc

Notes: AEs: Adverse Events, AGC: Advanced Gastric Cancer, AUC: Area Under the Plasma Concentration Versus Time Curve, BC: Breast Cancer, CRPC: Castration Resistant Prostate Cancer, CCA: Cervical cancer, ccRCC: Clear Cell Renal Cell Carcinoma, CL: Clearance, CBR: Clinical Benefit Rate, CRC: Colorectal Cancer, CR: Complete Response, CM: Cutaneous Melanoma, DFS: Disease-free survival, DLBCL: Diffuse Large B cell Lymphoma, DCR: Disease Control Rate, DLTs: Dose-limiting Toxicities, DOR: Duration of Response, EAC: Esophageal Adenocarcinoma Cancer, ESCC: Esophageal Squamous Cell Carcinoma, FL: Follicular Lymphoma, GAC: Gastric Adenocarcinoma Cancer, GC: Gastric Cancer, HCC: Hepatocellular Carcinoma Cancer, HNSC: Head and Neck Squamous Cell, HMs: Hematological Malignancies, MPR: Major Pathologic Response, Cmax: Maximum Observed Serum Concentration, mUC: Metastatic Urothelial Carcinoma, MM: Mucosal Melanoma, NHL: Non-Hodgkin Lymphoma, NSCLC: Non-small Cell Lung Cancer, ORR: Objective Response Rate, OR: Objective Response, OM: Ocular Melanoma, OS: Overall Survival, pCR: pathological Complete Response, PGA: Physician Global Assess, PCI: Potential Clinical Importance, PFS: Progression-free Survival, PASI: Psoriasis Area and Severity Index, RFS: Relapse-free Survival, RDI: Relative Dose Intensity, RCB: Residual Cancer Burden, RECIST: Response Evaluation Criteria in Solid Tumors, SAEs: Serious Adverse Events, STN: Significant Tumor Necrosis, SCLC: Small Cell Lung Carcinoma, SD: Stable Disease, Tmax: Time of Maximum Concentration, TTP: Time to Progress, TTR: Time to Response, TEAEs: Treatment-emergent Adverse Events, TNBC: Triple-negative Breast Cancer, UN: Urothelial Neoplasms, UCEC: Uterine Corpus Endometrial Carcinoma, VEGF-A: Vascular Endothelial Growth Factor-A

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