Immutep Limited (ASX: IMM) has observed statistically significant increases of biomarkers and RNA levels of immune activating genes linked to improved clinical outcomes in trials of a lung cancer treatment.
The clinical-stage biotechnology company has received promising new biomarker data from the TACTI-002/KEYNOTE-798 Phase II trial evaluating eftilagimod alpha (efti), a soluble, 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 to be presented at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting 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.
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,” Immutep CSO, Dr Frederic Triebel, said.
“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 metastatic 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, randomised 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.”
This biomarker data from the TACTI-002 Phase II is similar to the biomarker analysis from Immutep’s randomised, double-blind AIPAC Phase IIb trial in HER2-/HR+ metastatic breast cancer, which combined efti solely with paclitaxel chemotherapy and did not include any anti-PD-1 therapy.
In that trial, the number of circulating immune cells (monocytes, activated CD8 T cells) and CXCL10 serum levels with efti increased in a statistically significant fashion compared to baseline. The increase in pharmacodynamic markers, including ALC and CD8 T Cells, were also significantly linked to improved overall survival in the efti group.
