Immutep Limited provides an overview of the promising clinical data from the investigator-initiated INSIGHT-003 trial. The study evaluates a triple combination of eftilagimod alpha ("efti"), a soluble LAG-3 protein and MHC Class II agonist, with anti-PD-1 therapy (pembrolizumab) and doublet chemotherapy (carboplatin/pemetrexed) as front-line therapy for metastatic or advanced non-squamous non-small cell lung cancer (NSCLC). Prof. Salah-Eddin Al-Batran of the Frankfurt Institute of Clinical Cancer Research IKF and project lead stated: "Our broad experience evaluating efti across numerous solid tumour indications as monotherapy and in combination with immune checkpoint inhibitors has furthered understanding of the complementary mechanisms of action at play with this novel MHC class II agonist.

are building deeper insights into how efti jumpstarts the immune system to fight cancer through activation of dendritic cells, and its synergy with anti-PD-1 Therapy. The compelling data that proprietary MHC Class II agonist has generated in combination with immune checkpoint inhibitors for NSCLC patients positions efti as one of the more promising clinical candidates in immuno-oncology today. This is applicable regardless of patient PD-L1 expression, and particularly in patients with negative or low PD-L1 levels who typically respond poorly to checkpoint treatment and for which see strong potential with this IO-IO-chemo combination." Patients with high, low, and negative PD-L1 expression represent approximately 30%, 35%, and 35%, respectively, of the metastatic non-small cell lung cancer patient population.

Unlike many immuno-oncology (IO) combinations that focus on high PD-L1 expressing patients, compelling clinical results to date from efti's clinical trials suggest it may be uniquely positioned to effectively address low and high PD-L1 expressors through chemo-free IO-IO combinations, and potentially the entire NSCLC patient population with a focus on patients with TPS <50% with IO-IO-chemo combinations. INSIGHT-003 is an investigator-initiated study conducted by the Frankfurt Institute of Clinical Cancer research IKF. It is being run as the third arm (Stratum C) of the ongoing Phase IIGHT trial with Prof. Dr. Salah-Edd in Al-Batran as lead investigator.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer, head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track Designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).