Immutep Limited (IMMP), on Tuesday announced that it has received regulatory support for its pivotal TACTI-004 Phase III trial evaluating eftilagimod alfa or efti in combination with Merck's KEYTRUDA(pembrolizumab) and chemotherapy for the treatment of advanced or metastatic non-small cell lung cancer or NSCLC.
The trial has officially dosed its first patient, marking a key milestone in the study's progress.
The global Phase III study will assess the combination therapy in 756 patients with non-squamous or squamous tumors, regardless of PD-L1 expression. The trial's dual primary endpoints are progression-free survival and overall survival.
If successful, the results could establish a new standard-of-care treatment for NSCLC patients.
The trial follows promising data from earlier studies demonstrating that eftilagimod alfa, a first-in-class MHC Class II agonist, when combined with KEYTRUDA, activated the immune system and showed strong efficacy with a favorable safety profile.
Recruitment is underway at multiple clinical sites, with approvals already secured across several countries.
Immutep's CEO, Marc Voigt, expressed excitement about the potential of the TACTI-004 trial to provide a new treatment option for NSCLC patients, addressing a significant unmet need in one of the most common and deadly forms of cancer.
Currently, IMMP is trading at $1.85 up by 0.81 percent on the Nasdaq.
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June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.