Immutep and MSD to Test Efti with KEYTRUDA® in Phase III Trial

Immutep Limited, an Australian clinical-stage biotechnology firm specializing in LAG-3 immunotherapies for cancer and autoimmune diseases, has announced a vital collaboration with MSD (Merck & Co., Inc.) to conduct a Phase III trial evaluating the efficacy of eftilagimod alfa (efti) combined with MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), and standard chemotherapy for first-line treatment of metastatic non-small cell lung cancer (NSCLC). This collaboration is expected to explore new treatment paradigms and improve outcomes for NSCLC patients, regardless of their PD-L1 expression.

The TACTI-004 Phase III trial aims to enroll approximately 750 patients and will be conducted globally. This randomized, double-blind, controlled study will compare Immutep’s efti combined with KEYTRUDA and standard chemotherapy to the standard treatment regimen of KEYTRUDA, chemotherapy, and placebo. The dual primary endpoints for this study are progression-free survival and overall survival, with provisions for an interim analysis and a futility boundary to ensure timely and accurate assessment of the treatment’s effectiveness.

Immutep will oversee the TACTI-004 trial, while MSD will provide the necessary supply of KEYTRUDA. Through this partnership, the companies aim to secure marketing authorization and pursue relevant label indications for their respective drugs. Both parties retain the commercial rights to their products and may independently conduct additional clinical studies in various therapeutic areas.

This significant Phase III trial builds on the promising results seen in previous studies, including the TACTI-002 Phase II and TACTI-003 Phase IIb trials, which involved more than 350 patients. Data from these trials indicate that the combination of efti and KEYTRUDA can elicit strong immune responses and favorable clinical outcomes across all levels of PD-L1 expression in NSCLC patients. This combination has demonstrated both efficacy and a favorable safety profile, even among patients with low or negative PD-L1 expression who are typically less responsive to anti-PD-1 therapies.

Immutep’s CEO, Marc Voigt, emphasized the importance of this collaboration, noting the potential for this combined therapy to enhance patient outcomes in NSCLC, one of the most prevalent and deadly forms of cancer globally. Christian Mueller, SVP of Regulatory and Strategy at Immutep, highlighted the compelling data from earlier trials, which support the continued development of this novel immuno-oncology combination.

Lung cancer remains the second most common cancer worldwide, with non-small cell lung cancer (NSCLC) accounting for 80-85% of all cases. Annually, NSCLC affects approximately 1.87 million people and is the leading cause of cancer-related deaths. The innovative therapeutic approach combining efti and KEYTRUDA holds the promise of addressing this significant unmet medical need.

Eftilagimod alfa (efti) is a proprietary soluble LAG-3 protein and MHC Class II agonist developed by Immutep. It activates both the innate and adaptive immune systems by binding to MHC Class II molecules on antigen-presenting cells (APCs), thereby stimulating CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. This broad immune activation enhances the body’s ability to combat cancer, making efti a versatile candidate for combination therapies, including those with anti-PD-[L]1 immunotherapy and chemotherapy. Efti has received Fast Track designation from the FDA for first-line treatment of both NSCLC and head and neck squamous cell carcinoma (HNSCC).

Immutep continues to pioneer LAG-3 related therapies, leveraging their expertise to advance innovative treatment options for cancer and autoimmune diseases. This collaboration with MSD is a significant step toward potentially transforming the treatment landscape for NSCLC and providing new hope for patients battling this challenging disease.