Table 3.
Summarizes major ongoing trials evaluating LAG-3-directed therapies except the combination of nivolumab and relatlimab.
| Reference | Drugs | Phase | N | Population | Primary Endpoint |
|---|---|---|---|---|---|
|
NCT04811027 (TACTI-003) |
Eftilagimod alpha + pembrolizumab | 2 | 154 | First-line: unresectable R/M HNSCC | ORR |
| NCT04252768 (AIPAC-002) | Eftilagimod alpha + paclitaxel | 1 | 24 | HR+ metastatic breast cancer | Safety and tolerability |
| NCT05747794 (AIPAC-003) | Eftilagimod alpha or placebo + paclitaxel | 3 | 849 | HER2-neg/low metastatic breast cancer | OS, Aes, OBD |
| NCT03252938 | Eftilagimod alpha | 1 | 45 | IT, IP, SC alone or in combination in advanced solid tumors | Feasibility rate |
| NCT03005782 | Fianlimab with or without REGN2810 (Anti-PD1) | 1 | 333 | Advanced malignancies | DLTs AEs Serious AEs |
| NCT05352672 | Fianlimab + cemiplimab vs. pembrolizumab | 3 | 1590 | Previously untreated unresectable LA or metastatic melanoma | PFS |
| NCT04140500 | RO7247669 (PD1-LAG3 bispecific antibody) | 1 | 320 | Advanced and/or metastatic solid tumors | DLTs, AEs, ORR, DCR, DOR, PFS |
| NCT05419388 | RO7247669 | 1/2 | 80 | Previously untreated unresectable or metastatic melanoma | PFS |
| NCT05645692 | RO7247669 +/− tiragolumab vs. atezolizumab | 2 | 240 | Previously untreated advanced or metastatic UC ineligible for platinum-containing chemotherapy | ORR |
| NCT04785820 | RO7247669 vs. RO7121661 (PD1-TIM3 bispecific antibody) vs. nivolumab | 2 | 210 | Relapsed or intolerant to platinum-containing regimens in A/M SCCE | OS |
| NCT05508867 (KEYFORM-008) | favezelimab + pembrolizumab vs. physician’s choice chemotherapy | 3 | 360 | PD-(L)1-refractory, R/R classical Hodgkin lymphoma | PFS |
| NCT05064059 (MK-4280A-007) | favezelimab + pembrolizumab vs. SOC | 3 | 432 | Previously treated metastatic PD-L1 positive CRC | OS |
| NCT03598608 (MK-4280-003) | Favezelimab + pembrolizumab | 1/2 | 174 | Hematologic malignancies | DLTs, AEs, treatment discontinuation due to AEs |
| NCT04938817 (MK-3475-B98/KEYNOTE-B98) | Pembrolizumab + favezelimab or quavonlimab | 1/2 | 80 | PD-(L)1 refractory extensive-stage SCLC | DLTs AEs TRAEs ORR |
| NCT05695898 | XmAb23104 (PD1-ICOS) + XmAb22841 (CTLA-4-LAG3) | 1/2 | 46 | Metastatic melanoma refractory to prior ICI with and without CNS disease | TEAEs, irAEs, DLTs |
| NCT04150965 | BMS-986016 + Pomalidomide + dexamethasone (Arm B) | 1/2 | 104 | Relapsed and/or refractory MM | ORR, AEs |
ORR: objective response rate; AEs: adverse events; DLTs: dose-limiting toxicities; DCR: disease control rate; DOR: duration of response; PFS: progression-free survival; IT: intra-tumoral; IP: intra-peritoneal; SC: subcutaneous; OBD: optimal biological dose; TEAEs: treatment-emergent adverse events; TRAEs: treatment-related adverse events; irAE: immune-related adverse event; CNS: central nervous system; SCLC: small cell lung cancer; MM: multiple myeloma; ICI: immune checkpoint inhibitor; CRC: colorectal cancer; OS: overall survival; R/R: relapsed and/or refractory; SCCE: squamous cell carcinoma of the esophagus.