Immutep Ltd (ASX: IMM; NASDAQ: IMMP) has announced the initiation of its pivotal TACTI-004 Phase III clinical trial, a significant step forward in the treatment of first-line metastatic non-small cell lung cancer (NSCLC). The trial, which has received regulatory approval from the Australian Therapeutic Goods Administration, marks Immutep's transition into a Phase III clinical development company.
The global study will evaluate eftilagimod alfa (efti), a soluble LAG-3 protein that activates dendritic cells, in combination with MSD’s KEYTRUDA® (pembrolizumab) and chemotherapy. This regimen will be compared against KEYTRUDA® in combination with chemotherapy and a placebo. The trial aims to enroll approximately 750 patients with metastatic NSCLC across more than 150 clinical sites in over 25 countries. Patient enrollment is expected to begin in the first quarter of 2025.
Trial Design and Endpoints
The TACTI-004 trial is designed as a 1:1 randomized, double-blind, multinational, controlled study. It features dual primary endpoints of progression-free survival (PFS) and overall survival (OS). These endpoints are critical for assessing the efficacy of the new treatment regimen and its potential to improve outcomes for patients with metastatic NSCLC.
Eftilagimod Alfa: A Novel LAG-3 Immunotherapy
Eftilagimod alfa is Immutep's lead immunotherapy candidate. It is designed to activate dendritic cells through Lymphocyte Activation Gene-3 (LAG-3), potentially enhancing the immune response against cancer cells. The combination of eftilagimod alfa with pembrolizumab and chemotherapy is intended to provide a synergistic effect, improving treatment outcomes in NSCLC patients regardless of PD-L1 expression.
Management Commentary
"The receipt of regulatory approval from the Australian Therapeutic Goods Administration to commence the TACTI-004 trial is a significant milestone for Immutep and marks its transformation into a Phase III company," said Marc Voigt, CEO of Immutep. "This also represents a key step towards potentially establishing a new standard of care for patients with metastatic NSCLC. We are confident based on the strength of eftilagimod alfa’s data that it can make a meaningful difference in cancer patients’ lives, and we eagerly anticipate enrolling the first patient into this important study during the first quarter of 2025."
Regulatory Progress and Global Expansion
Immutep has successfully completed regulatory submissions to the vast majority of the more than 25 countries that will be part of the global TACTI-004 trial. Australia represents the first approval by all regulatory authorities including ethics committees and Institutional Review Boards (IRB). The Company also anticipates full approval in the United Kingdom shortly as it has received clearances from the Medicines and Healthcare products Regulatory Agency (MHRA) and the Research Ethics Committee (REC). Additional approvals from multiple countries are expected in the weeks and months ahead.
About Non-Small Cell Lung Cancer
Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases. Despite advances in treatment, metastatic NSCLC remains a significant challenge, with a high unmet medical need for more effective therapies. The TACTI-004 trial aims to address this need by evaluating a novel combination immunotherapy regimen that could potentially improve survival outcomes for these patients.
