This clinical trial will also include paclitaxel in the treatment of metastatic breast cancer
Immutep – a company dedicated to developing novel LAG-3 immunotherapies for cancer and autoimmune diseases – has announced the initiation of the AIPAC-003 (Active Immunotherapy, Eftilagimod Alpha and PAclitaxel) study.
This study is an integrated Phase 2/3 trial evaluating eftilagimod alpha (also known as efti) in combination with paclitaxel for the treatment of metastatic HER2-negative/low breast cancer (MBC).
It has already received regulatory approval in the United States and Institutional Review Board approval in Spain. In the meantime, approvals in several additional countries are expected to follow soon. The first patients are expected to be enrolled later this year.
Efti is seen as well positioned to improve clinical outcomes with standard-of-care chemotherapy. Stimulation of antigen-presenting cells such as dendritic cells and monocytes triggers a broad immune response, including an increase in cytotoxic CD8+ T cells, combined with cancer-targeting chemo-induced tumor antigens.
This interaction was demonstrated by the promising safety and efficacy of the AIPAC Phase 2b trial. This included an improvement in median overall survival (mOS), a statistically significant improvement in mOS across three prespecified subgroups, and a statistically significant reduction in cytotoxic CD8 T cells that correlated with improvement. Includes significant boost. OS.
Immutep CEO Marc Voigt is encouraged by the results. – Care chemotherapy.
He added: Disease progression, and to new primary endpoints of overall survival. “
A randomized, double-blind, placebo-controlled Phase 3 component will follow shortly, depending on the outcome of Phase 2, potential regulatory action and resources.