Immutep Announces New Biomarker Data from TACTI-002 Phase II in First Line Non-Small Cell Lung Cancer

Media Release

• Statistically significant increases of Th1 biomarkers (IFN-gamma, CXCL-10), circulating immune cells (lymphocytes), and RNA levels of immune activating genes were observed and linked to improved clinical outcomes
• Early increase in absolute lymphocyte count is correlated with the positive Overall Survival results in non-small cell lung cancer patients recently reported at ESMO 2023, and is a potential on-treatment biomarker for clinical benefit
• Similar immune response biomarkers in the blood were seen in the double-blind, randomized AIPAC Phase IIb trial, which combined efti solely with chemotherapy and did not include any anti-PD-1 therapy
  
  

SYDNEY, AUSTRALIA, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces new biomarker data from the TACTI-002/KEYNOTE-798 Phase II trial evaluating eftilagimod alpha (“efti”), a soluble LAG-3 protein and first-in-class MHC Class II agonist administered subcutaneously, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab) as first-line treatment for patients with previously untreated unresectable or metastatic non-small cell lung cancer (NSCLC).

The biomarker data related to blood samples from TACTI-002 patients presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2023 substantiates efti’s unique immune system stimulation and can be linked to its success in first line treatment of metastatic NSCLC patients, including the positive Overall Survival results recently reported at ESMO Congress 2023.

Dr Frederic Triebel, Immutep CSO, said, “Immunomonitoring of blood cells is of prime importance when one would like to understand the effect of a systemic immunostimulant injected subcutaneously, like efti is. Importantly, the pharmacodynamic data from efti in combination with pembrolizumab is associated with the 35.5-month median Overall Survival in first-line treatment of metastastic non-small cell lung cancer patients expressing PD-L1 (TPS >1%) that we recently reported at ESMO 2023. Similar to the immune response biomarker data seen in efti’s double-blind, randomized Phase IIb trial in HER2-/HR+ metastatic breast cancer, this data further confirms efti’s unique stimulation of the immune system, which may help patients live longer.”