Immutep and MSD Launch Phase 2b Trial of Eftilagimod Alpha Combined with Keytruda as First-Line Therapy for Head and Neck Squamous Cell Carcinoma

Today, Immutep announced that it has entered into a clinical trial collaboration agreement with a subsidiary of Merck Sharp & Dohme (MSD). The companies will conduct a Phase 2b clinical trial to evaluate the efficacy of combining Immutep’s lead candidate therapy, eftilagimod alpha (also known as efti or IMP321), with MSD’s PD-1 inhibitor Keytruda versus Keytruda monotherapy as first-line treatment for patients with head and neck squamous cell carcinoma (HNSCC). Eftilagimod alpha is a soluble LAG-3 fusion protein that has demonstrated the ability to enhance Keytruda response rates in clinical trials evaluating the combination therapy for non-small cell lung cancer.

Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer worldwide, with approximately 800,000 new cases diagnosed and about 450,000 deaths in 2018. HNSCC is characterized by aggressive invasion, a complex genetic background, and difficulty in treatment. Furthermore, HNSCC is often associated with significant psychological stress and reduced quality of life, underscoring the urgent need for more effective therapeutic options for patients.

The LAG-3 protein regulates signaling pathways in T lymphocytes and antigen-presenting cells (APCs), playing a crucial role in adaptive immune responses. Eftilagimod alpha is a potential first-in-class soluble LAG-3 fusion protein. By binding to major histocompatibility complex class II (MHC II) molecules on the surface of APCs, it activates APCs, leading to an increase in the number and activation of cytotoxic CD8-positive T cells. Through this mechanism, soluble LAG-3 protein enhances immune responses against cancer antigens. Keytruda enhances T cell-mediated anti-cancer immune responses by blocking the PD-1 signaling pathway, which has immunosuppressive functions. The two therapies have complementary mechanisms of action.

“We are pleased to deepen our collaboration with MSD. Conducting the Phase 2b clinical trial will enable us to explore the potential of combination therapy in first-line treatment settings with high unmet medical needs,” said Mr. Marc Voigt, Chief Executive Officer of Immutep. Under the agreement, patient enrollment for the Phase 2b clinical trial, named TACTI-003, is scheduled to begin in mid-year this year, with an expected recruitment of 160 patients with head and neck squamous cell carcinoma (HNSCC).

Note: This article is intended to introduce medical and health research and does not constitute a recommendation for treatment plans. For guidance on treatment options, please consult a licensed healthcare provider at a reputable hospital.

References:

[1] IMMUTEP ENTERS SECOND COLLABORATION WITH MSD FOR A NEW RANDOMISED PHASE IIB TRIAL IN HEAD AND NECK CANCER. Retrieved March 16, 2021, from https://www.immutep.com/files/content/investor/press-release/2021/Immutep%20Collaborates%20with%20MSD%20for%20Phase%20IIB%20Head%20&%20Neck%20Trial%20-%2016Mar2021.pdf

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