Efti plus pembrolizumab was well-tolerated and revealed signs of antitumor activity in patients with NSCLC resistant to PD-(L)1 inhibitors, warranting further investigation. Trial registration number: NCT03625323.

E+P is well tolerated with positive efficacy data and should be investigated further in HNSCC.

Efti plus pembrolizumab was safe and showed encouraging antitumor activity and pharmacodynamic effects in 2nd line HNSCC patients, thus supporting further evaluation of this combination in earlier treatment lines.

P1, N=0, Withdrawn, Immutep S.A.S. | N=24 --> 0 | Not yet recruiting --> Withdrawn

30 mg efti appears to be feasible and safe.

When combined with a PD-1 checkpoint inhibitor, the soluble LAG3 drug eftilagimod alpha activates antigen-presenting cells, offering deep and durable responses against non-small cell lung cancer. Even patients whose tumors express low levels of PD-L1 experienced an anticancer benefit.

P2 | "Early & sustained increases of circulating CXCL-10 & IFN-gamma levels were observed. Conclusions E + P is safe & shows encouraging antitumor activity in 1st line metastatic NSCLC patients unselected for PD-L1, warranting late-stage clinical investigation."

Secondary EPs include overall survival, ORR according to iRECIST, time to and duration of response, disease control rate, progression-free survival, the occurrence of anti-efti -specific antibodies, safety, and quality of life. Exploratory endpoints comprise biomarkers.

P1, N=24, Not yet recruiting, Immutep S.A.S. | Trial completion date: Feb 2024 --> Feb 2026 | Trial primary completion date: Jun 2023 --> Jun 2025

Efti in combination with pembrolizumab is safe and shows encouraging signs of antitumor activity in truly PD-1/PD-L1 refractory 2nd line NSCLC pts.

P2, N=189, Active, not recruiting, Immutep S.A.S. | Trial completion date: May 2023 --> Nov 2023

E + P is safe and shows encouraging antitumor activity in first-line metastatic NSCLC patients unselected for PD-L1, warranting further investigation.

Exploratory endpoints comprise biomarkers. The study has been approved by relevant competent authorities, ethic committees and IRBs.

P2, N=50, Not yet recruiting, Taizhou EOC Pharma Co., Ltd.

P1, N=12, Completed, Taizhou EOC Pharma Co., Ltd. | Recruiting --> Completed | N=18 --> 12 | Trial completion date: Sep 2020 --> Dec 2021 | Trial primary completion date: Aug 2019 --> Dec 2021

IMP321 and relatlimab are promising monoclonal antibodies targeting LAG3 in melanoma. Finally, high FGL1 and LAG3 expression induces EGFR-TKI and gefitinib resistance, and anti-PD-1 therapy resistance, respectively. We present a comprehensive overview of the role of LAG3/FGL1 in cancer, suggesting novel anti-tumor therapy strategies.

Both responses were reported in pts pre-treated with chemo + PD-1 and under therapy since 7+ and 12+ months at data cut-off. Conclusions Efti in combination with pembrolizumab is safe and shows encouraging signs of antitumor activity in PD-1 refractory 2 nd line NSCLC pts.

P2, N=189, Active, not recruiting, Immutep S.A.S. | Recruiting --> Active, not recruiting

P2; Not yet recruiting --> Recruiting | Trial primary completion date: Apr 2023 --> Jul 2023

For further investigation of this combination, a 1st line HNSCC trial (NCT04811027) has been initiated. Trial Registration NCT03625323

Efti in combination with pembrolizumab is safe and shows encouraging antitumor activity in platinum pre-treated 2nd line HNSCC patients.