Pharma Focus Europe

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

Monday, June 03, 2024

Immutep Limited (ASX: IMM; NASDAQ: IMMP), a leading biotechnology firm specializing in the development of LAG-3 immunotherapies, has announced a pivotal collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA) to advance the treatment landscape for metastatic non-small cell lung cancer (NSCLC). The collaboration involves a clinical trial collaboration and supply agreement to evaluate the efficacy of eftilagimod alfa (efti) in combination with MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), alongside chemotherapy in a Phase III trial.

This partnership aims to redefine the standard of care by enhancing clinical outcomes and extending the benefits of immunotherapy to a broader spectrum of NSCLC patients, regardless of PD-L1 expression levels. The upcoming TACTI-004 trial, designed as a 1:1 randomised, double-blind study, will enroll approximately 750 NSCLC patients globally, including both squamous and non-squamous subtypes.

Immutep, highlighted the significance of this collaboration, emphasizing efti's potential to augment the therapeutic efficacy achieved with KEYTRUDA in NSCLC. The agreement builds upon the success of previous collaborations, notably the TACTI-002 and TACTI-003 trials, which collectively treated over 350 patients, showcasing promising clinical outcomes.

Central to this collaboration is Immutep's efti, a proprietary soluble LAG-3 protein and MHC Class II agonist, known for its ability to stimulate both innate and adaptive immunity in cancer treatment. Efti's mechanism of action involves activation and proliferation of various immune cell types, including cytotoxic T cells and dendritic cells, thereby enhancing the immune system's ability to combat cancer.

Christian Mueller, Immutep’s SVP, Regulatory and Strategy, echoed Voigt's sentiments, expressing confidence in efti's potential to enhance patient outcomes in NSCLC. Mueller highlighted the robust trial design of TACTI-004, featuring dual primary endpoints of progression-free and overall survival, aimed at confirming the differentiated efficacy observed in previous trials.

Lung cancer, being the second most prevalent cancer globally, underscores the urgent need for innovative treatment modalities. NSCLC, which accounts for the majority of lung cancer cases, presents a formidable challenge, impacting millions of individuals annually.

In conclusion, Immutep's collaboration with MSD represents a significant milestone in the pursuit of advancing immunotherapy for NSCLC. The synergistic combination of efti and KEYTRUDA holds immense promise in reshaping the treatment paradigm for this debilitating disease, offering hope to patients worldwide.



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