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

NextEdge Admin

03 Jun 2024

3 min 5 sec

NSCLC,anti-PD-1 therapy,LAG-3 immunotherapy

Immutep Limited has partnered with MSD (Merck & Co., Inc.) to conduct a Phase III clinical trial, TACTI-004, evaluating their novel LAG-3 immunotherapy, eftilagimod alfa (efti), in combination with MSD’s anti-PD-1 therapy, KEYTRUDA®, and chemotherapy for metastatic non-small cell lung cancer (NSCLC). The trial aims to establish a new standard of care by improving clinical outcomes for responders and expanding the patient population benefiting from treatment, regardless of PD-L1 expression.

TACTI-004 will be a randomized, double-blind study involving approximately 750 NSCLC patients worldwide. It will compare efti plus KEYTRUDA and chemotherapy against standard-of-care KEYTRUDA, chemotherapy, and placebo. The trial’s primary endpoints are progression-free and overall survival, with an interim analysis planned.

Immutep’s CEO, Marc Voigt, expressed enthusiasm for advancing immunotherapy in NSCLC, citing previous successful trials combining efti with KEYTRUDA. This collaboration builds on the positive data from earlier studies, TACTI-002 and TACTI-003, which treated over 350 patients collectively. Immutep will conduct TACTI-004, while MSD will provide KEYTRUDA.

Efti’s mechanism involves activating dendritic cells and the immune system, enhancing anti-cancer responses, particularly in patients with low PD-L1 expression. Previous trials showed efficacy in such patients, who typically respond less to anti-PD-1 therapy. Importantly, the combination therapy has been well-tolerated.

Christian Mueller, Immutep’s SVP, Regulatory and Strategy, highlighted the potential of efti to improve patient outcomes in NSCLC, building upon KEYTRUDA’s success. Lung cancer is a significant health concern globally, and NSCLC accounts for a large portion of cases.

Efti, Immutep’s proprietary LAG-3 immunotherapy, stimulates both innate and adaptive immunity to fight cancer. It is being evaluated for various solid tumors, including NSCLC, head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer, with Fast Track designation from the FDA in certain indications.

Immutep is dedicated to developing innovative treatments harnessing LAG-3 biology for cancer and autoimmune diseases, aiming to provide new options for patients and maximize shareholder value.