Immutep Begins Dosing in TACTI-004 Phase III Lung Cancer Trial

Immutep Limited, a prominent biotechnology firm specializing in immunotherapy for cancer and autoimmune diseases, has achieved a notable advancement in its ongoing clinical efforts. The company announced that the first patient has been successfully administered the new treatment as part of the pivotal TACTI-004 Phase III trial, marking a significant step forward. This trial aims to assess the efficacy of eftilagimod alfa (efti), a pioneering MHC Class II agonist, in conjunction with MSD's KEYTRUDA® (pembrolizumab) and chemotherapy as a first-line treatment for patients suffering from advanced or metastatic non-small cell lung cancer (NSCLC).

The milestone was reached at Calvary Mater Newcastle Hospital in Australia, where Dr. Ina Nordman reported the successful dosing of the first patient. Dr. Nordman expressed enthusiasm for the trial, acknowledging the persistent need for novel treatments in the realm of non-small cell lung cancer that can effectively and safely extend patient survival. The innovative combination involving efti and KEYTRUDA has previously demonstrated strong efficacy across various PD-L1 levels, coupled with a favorable safety profile in multiple lung cancer studies. The goal of this study is to confirm the potential of this novel therapy to offer patients a robust new treatment alternative.

Marc Voigt, CEO of Immutep, highlighted the importance of this milestone in the company's history. The TACTI-004 study holds the promise to redefine the standard-of-care for patients with advanced or metastatic NSCLC, provided it successfully demonstrates a significant and statistically meaningful improvement in survival outcomes. If successful, this could lead to a substantial shift in clinical practice for treating this type of cancer.

Frédéric Triebel, Immutep's Chief Scientific Officer, elaborated on the study's design, indicating that following extensive regulatory interactions, including consultations with the US FDA under Project Optimus, the trial will proceed with the 30 mg subcutaneous dosing of efti. This approach has shown efficacy in activating the immune system to combat NSCLC across various PD-L1 expressions, all while maintaining an excellent safety profile compared to traditional therapies. The trial aims to deliver high rates of durable responses and strong survival outcomes.

Recruitment for the TACTI-004 trial is currently ongoing, with multiple clinical sites being activated across various countries. The global trial plans to enroll approximately 756 patients at over 150 clinical venues in more than 25 countries. The study will investigate the dual primary endpoints of progression-free survival and overall survival, seeking to provide a comprehensive understanding of the treatment's potential benefits.

Non-small cell lung cancer remains a major health challenge, accounting for 80-85% of lung cancer diagnoses. The disease is frequently detected at an advanced stage, and the survival rate for patients beyond five years post-diagnosis is below 30%. Consequently, there is a significant demand for additional treatment options to address this unmet need.

The TACTI-004 trial represents Immutep's commitment to advancing innovative therapies that may provide meaningful improvements in patient outcomes. By leveraging their expertise in Lymphocyte Activation Gene-3 (LAG-3) related therapeutics, Immutep continues to push the boundaries of cancer treatment, with the aim of introducing breakthrough options for patients worldwide.