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) |
| Â | NCT04653038 | I | Recruiting | Melanoma | NA | NA | Single agent |
| Â | 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) |
| Â | NCT03625323 | II | Recruiting | NSCLC HNSCC | NA | NA | Â |
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 |