Immutep Ltd. has announced the successful completion of the US FDA's Project Optimus requirements, confirming 30mg of eftilagimod alfa (efti) as the optimal biological dose for its oncology pipeline. This regulatory milestone paves the way for future Biological License Applications (BLA) and supports the ongoing global Phase III TACTI-004 (KEYNOTE-F91) trial. The trial is evaluating efti in combination with Merck's KEYTRUDA® (pembrolizumab) and chemotherapy as a first-line treatment for advanced or metastatic non-small cell lung cancer, with clinical sites now in the process of opening in the United States. No new grant or funding announcement involving multiple organizations was disclosed.
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