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Table 4 Summary of clinical trials utilizing agents targeting LAG3 alone or in combination with others

From: Fibrinogen-like protein 1 (FGL1): the next immune checkpoint target

Drug Clinical trial number Phase Status Tumor type Clinical efficacy Safety Details
MGD013 (tebotelimab) NCT04212221 I/II Recruiting HCC NA NA In combination with brivanib alaninate (ZL-2301)
  NCT04653038 I Recruiting Melanoma NA NA Single agent
  NCT04634825 II Recruiting HNSCC NA NA Tebotelimab or retifanlimab (PD-1 antibody) plus enoblituzumab (B7-H3 antibody)
  NCT03219268   Active, not recruiting Neoplasms (unresectable or metastatic) NA Fatigue: 19%
Nausea: 11%
Grade ≥ 3 TRAEs: 23.2%
irAEs were consistent with events observed in anti-PD-1 antibodies
BMS-986016
(relatlimab)
NCT03470922 II/III Active, not recruiting Melanoma (unresectable or metastatic) NA NA In combination with nivolumab (anti-PD-1 mAb)
REGN3767 (fianlimab) NCT03005782 I Recruiting Malignancies ORR: 64% (21 of 33 patients; 3 complete responses, 18 partial responses) Monotherapy TRAE
Nausea: 22.2%
Increased ALT and AST: 3.7%
Combination therapy TRAE
Fatigue: 31%
Rash: 23%
Grade ≥ 3 irAEs:
Hypothyroidism: 2.4%
In combination with Cemiplimab (REGN2801)
BI 754111 NCT03156114
NCT03433898
NCT03697304
NCT03780725
I/II Active, not recruiting/
Recruiting/
completed
Carcinoma, NSCLC,
Head and neck neoplasms
NA Any AEs: 86.7%;
Any irAEs: 21.1%
IRRs: 4.9%
Hypothyroidism: 3.2%
In combination with 754091 (anti-PD-1 mAb)
IMP321 (eftilagimod alpha) NCT02676869 I Completed Stage IV/III melanoma ORR: 33–50% No dose-limiting toxicities
Main AE: IRR
In combination with
pembrolizumab (anti-PD-1 mAb)
  NCT03625323 II Recruiting NSCLC
HNSCC
NA NA  
BMS-986213
(relatlimab, nivolumab)
NCT03662659 II Active, not recruiting GC/GEJC NA NA Relatlimab/nivolumab, given in combination with chemotherapy
BMS-986016
(relatlimab)
NCT03607890 II Recruiting MSI-H tumors NA NA Utilized in patients with MSI-H solid tumors refractory to prior PD-(L)1 therapy
LAG525
(IMP701)
NCT03365791 II Completed Advanced solid and hematologic malignancies NA AEs: 98.7%
Fatigue: 36.84%
Nausea: 34.21%
SAEs: 42.1%
Pneumonia: 6.58%
In combination with
spartalizumab (PDR001) (anti-PD-1 mAb)
Sym022 NCT0331141 I Recruiting Metastatic cancer
solid tumors
lymphoma
NA Grade ≥ 3 TRAEs:
Increased CPK: 10%
Decreased lymphocytes: 5% Hypophysitis: 5%
In combination with Sym021 (anti-PD-1) or Sym023 (anti-TIM3)
LBL-007 NCT04640545 I Recruiting Advanced melanoma NA NA In combination with toripalimab (anti-PD-1 mAb)
FS0118 NCT03440437 I/II Recruiting Advanced malignancies NA NA Single agent
TSR-033 NCT03250832 I Active, not recruiting Neoplasms NA NA TSR-033/dostarlimab (anti-PD-1 mAb) in combination with chemotherapy
  1. ALT: alanine aminotransferases; AST: aspartate aminotransferases; MSI-H: high levels of microsatellite instability; GEJC: esophagogastric junction cancer; HNSCC: head and neck squamous cell carcinoma; irAE: immune-related adverse event; IRR: infusion-related reaction; NA: not available; ORR: objective response rate; TRAE: treatment-related adverse event; SAE: severe adverse event; mAb: monoclonal antibody