Immutep (ASX:IMM) has announced the start of its pivotal TACTI-004 Phase III clinical trial. This trial, targeting first-line metastatic non-small cell lung cancer, has received regulatory approval from the Australian Therapeutic Goods Administration. It marks an important shift for Immutep towards becoming a Phase III company.
Immutep is advancing its clinical-stage pipeline with the initiation of the TACTI-004 Phase III trial. This trial will evaluate the efficacy of eftilagimod alfa in combination with KEYTRUDA and chemotherapy against a control group receiving KEYTRUDA and chemotherapy with a placebo. The trial targets 750 patients at over 150 sites in more than 25 countries. Initial regulatory approval has been secured in Australia, with further approvals expected globally. Immutep aims to innovate cancer treatments and enhance shareholder value as it progresses into a Phase III company.
We are excited to initiate this pivotal Phase III trial as it represents a significant milestone for Immutep. The regulatory approval from the Australian Therapeutic Goods Administration is an important step forward in our journey to develop innovative treatments for patients with metastatic NSCLC. We look forward to enrolling patients globally and advancing this important study.