Immutep (ASX:IMM; NASDAQ:IMMP), a leading biotechnology firm specialising in LAG-3 immunotherapy, has achieved a significant milestone in its quest to redefine cancer treatment. Today, the company announced positive feedback from the US Food and Drug Administration (FDA) regarding its planned TACTI-004 Phase III trial of eftilagimod alfa (efti), a novel LAG-3 therapy.

The TACTI-004 trial aims to evaluate efti in combination with KEYTRUDA (pembrolizumab) and standard chemotherapy for first-line metastatic non-small cell lung cancer (1L NSCLC), irrespective of PD-L1 expression. This regulatory feedback, obtained through a Type C meeting with the FDA, complements prior interactions with the Paul-Ehrlich-Institut (PEI) and the Spanish Agency for Medicines and Health Products (AEMPS), finalizing the trial's design preparations.

"We are pleased with the FDA's feedback as this allows us to successfully conclude our regulatory preparation for the TACTI-004 registrational trial," commented Christian Mueller, Immutep's Senior Vice President of Regulatory and Strategy. "This represents a key milestone in our late-stage development process for efti centered on potentially driving a new standard of care globally in the treatment of non-small cell lung cancer."

Efti, Immutep's proprietary soluble LAG-3 protein and MHC Class II agonist, activates both innate and adaptive immunity against cancer cells. Its mechanism involves binding to MHC Class II molecules on antigen presenting cells, leading to the activation of cytotoxic T cells, helper T cells, dendritic cells, and other immune components crucial for combating cancer.

The TACTI-004 Phase III trial, a randomized, double-blind study, plans to enroll approximately 750 NSCLC patients globally. It will compare the efficacy of efti in combination with KEYTRUDA and chemotherapy against the current standard treatment. The trial's primary endpoints include progression-free survival and overall survival, with interim analyses to assess efficacy throughout the study.

Immutep's innovative approach has garnered Fast Track designations from the FDA for efti in first-line head and neck squamous cell carcinoma (HNSCC) and first-line NSCLC, underscoring its potential to redefine cancer therapy standards. With promising efficacy data from earlier trials, Immutep aims to establish efti as a pivotal component in combating various solid tumors, including NSCLC and metastatic breast cancer.

The company remains optimistic about the implications of this FDA feedback, believing it will pave the way for advancing efti's role in cancer treatment globally. As Immutep continues to drive innovation in immunotherapy, collaborations with regulatory authorities and strategic partners like Merck Sharp & Dohme LLC (MSD) remain pivotal to achieving its clinical milestones and transforming patient outcomes.