Immutep Announces FDA Approval for Phase III Non-Small Cell Lung Cancer Trial Design

Immutep Limited, a clinical-stage biotechnology company, has announced a significant milestone in its development of novel LAG-3 immunotherapies for cancer and autoimmune diseases. The company received positive feedback from the US Food and Drug Administration (FDA) regarding the design of its TACTI-004 Phase III trial. This trial will evaluate the efficacy of eftilagimod alfa (efti) combined with KEYTRUDA® (pembrolizumab) and standard chemotherapy for first-line metastatic non-small cell lung cancer (NSCLC) treatment, regardless of PD-L1 expression levels.

Feedback from the FDA, along with prior input from the Paul-Ehrlich-Institut (PEI) and the Spanish Agency for Medicines and Health Products (AEMPS), has finalized the regulatory groundwork for the TACTI-004 trial. This marks a crucial step forward in developing a treatment for both non-squamous and squamous NSCLC patients eligible for anti-PD-1 therapy, whether they have high, low, or no PD-L1 expression.

The TACTI-004 Phase III trial will enrol approximately 750 patients. This trial builds on the positive efficacy and safety data obtained from the TACTI-002 Phase II and INSIGHT-003 trials. Christian Mueller, Immutep’s Senior Vice President of Regulatory and Strategy, expressed satisfaction with the FDA’s feedback, which allows the company to conclude its regulatory preparations for the trial. Mueller highlighted that this milestone is vital for advancing efti as a potential new global standard of care in treating NSCLC. The combination of efti and KEYTRUDA has shown robust efficacy and a favorable safety profile in first-line NSCLC patients, irrespective of PD-L1 expression.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. The TACTI-004 trial will be a 1:1 randomized, double-blind, multinational, controlled clinical study. It will compare the combination of Immutep’s efti, KEYTRUDA, and chemotherapy against the standard of care, which includes KEYTRUDA, chemotherapy, and a placebo. The trial's dual primary endpoints are progression-free survival and overall survival, with a prespecified futility boundary and a pre-planned interim analysis. This pivotal trial aims to recruit around 750 NSCLC patients, including both squamous and non-squamous subtypes, and will be conducted globally.

Eftilagimod alfa (efti) is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist designed to stimulate both innate and adaptive immune responses for cancer treatment. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC Class II molecules on APCs, leading to the activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, natural killer (NK) cells, and monocytes. It also upregulates key biological molecules like IFN-ƴ and CXCL10, enhancing the immune system’s capacity to combat cancer. Efti is being evaluated for various solid tumors, including NSCLC, head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favorable safety profile enables it to be combined with anti-PD-[L]1 immunotherapy and/or chemotherapy. The FDA has granted efti Fast Track designation for first-line HNSCC and first-line NSCLC.

Immutep is a pioneer in the field of Lymphocyte Activation Gene-3 (LAG-3) immunotherapy. The company’s diverse product portfolio leverages LAG-3's unique ability to modulate the immune response, aiming to bring innovative treatment options to patients and create value for shareholders.

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