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