Immutep Limited announced that it has entered into a clinical trial collaboration and supply agreement with MSD (Merck & Co. Inc., Rahway, NJ, USA), through a subsidiary, to evaluate eftilagimod alfa (efti) in combination with MSD's anti-PD-1 therapy, KEYTRUDA®? (pembrolizumab) and chemotherapy for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in a pivotal Phase III trial.

The potential for efti in combination with KEYTRUDA and chemotherapy is to set a new standard of care, by strengthening clinical outcomes for responders and broadening the number of patients who respond across the entire NSCLC patient population regardless of PD-L1 expression. TACTI-004 will be a 1:1 randomised, double-blind, multinational, controlled clinical study to evaluate Immutep's efti in combination with KeyTRUDA and standard chemotherapy compared to the standard-of-care combination of KEYTRUDA, chemotherapy and placebo in first-line metastatic NSCLC, regardless of PD-L1 expressions. In this pivotal PD-L1 all comer trial, the dual primary endpoints will be progression-free and overall survival with a prespecified futility boundary and a pre-planned interim analysis.

The clinical data generated by the innovative immuno-oncology combination of Immutep's MHC Class II agonist andMSD's anti-PD- 1-line therapy in the TACTI-002 Phase II trial in first-line NSCLC regardless of PD-L 1 expression has led to oral presentations at the ASCO, SITC, and ESMO conferences. Efti's unique activation of dendritic cells (the most potent professional antigen-presenting cells) engages the adaptive and innate immune system to drive a broad anti-cancer immune response, including proliferation of cytotoxic T cells that complements anti-PD-1 therapy in first-line NSCLc across all levels of PD-L1 expression (negative, low, and high). Notably, over 75% of the patients in both the TACTI-002 and INSIGHT-003 clinical trials had a PD-L1 Tumor Proportion Score (TPS) of 1-3. KEYTRUDA®?

is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc.,Rahway, NJ, USA. Its favourable safety profile enables various combinations, including with anti-PD-[L1 immunotherapy and/or chemotherapy.

Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).