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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