Immutep reports clinical data from INSIGHT-003 trial

Immutep provides an overview of the promising clinical data from the investigator-initiated INSIGHT-003 trial. The study evaluates a triple combination of eftilagimod alpha, a soluble LAG-3 protein and MHC Class II agonist, with anti-PD-1 therapy and doublet chemotherapy as front-line therapy for metastatic or advanced non-squamous non-small cell lung cancer. The poster presentation at ESMO Congress 2023 showed the triple combination therapy continues to be well-tolerated with strong signals of efficacy. The clinical data included a positive median Overall Survival that was not reached and encouraging median Progression Free Survival of 10.1 months. Additionally, the IO-IO-chemo combination achieved a 71.4% Overall Response Rate 90.5% Disease Control Rate, and showed positive early trends in 12-month OS and PFS rates. Notably, 81% of patients in the trial had a PD-L1 Tumor Proportion Score of less than50%, including PD-L1 negative and PD-L1 low, who are less responsive to anti-PD-1 based therapy as compared to PD-L1 high patients. In this difficult-to-treat NSCLC patient population with PD-L1 TPS less than50%, the triple combination’s 70.6% ORR 10.9-month median PFS and 10.1 month median PFS compare favourably to the reported 40.8% response rate, 9.2-month median PFS, and 6.2-month median PFS from a registrational trial of anti-PD-1 and doublet chemotherapy.2 Furthermore, the triple combination appears to be safe, and the addition of efti does not appear to increase the toxicity of the standard chemo-immunotherapy regimen. 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 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 less than50% with IO-IO-chemo combinations.