Immutep (ASX: IMM; NASDAQ: IMMP) has announced the completion of patient enrollment in the randomized Phase II portion of the AIPAC-003 clinical trial. This trial is focused on evaluating eftilagimod alpha ('efti') in combination with paclitaxel for patients with metastatic breast cancer who have exhausted endocrine therapy options. The study, conducted across 22 clinical sites in Europe and the United States, enrolled 65 patients and is designed to determine the optimal biological dose of efti, aligning with the FDA's Project Optimus initiative.
Trial Design and Objectives
The AIPAC-003 trial is a Phase II study randomizing patients 1:1 to receive either 30mg or 90mg of efti in combination with paclitaxel. The primary objective is to determine the optimal biological dose (OBD) of efti, consistent with the FDA's Project Optimus initiative, which aims to optimize dosing in oncology drug development. The trial enrolled patients with metastatic hormone receptor positive (HR+), HER2-negative/low, or triple-negative breast cancer who had progressed after endocrine therapy, including CDK4/6 inhibitors.
Patient Population and Locations
The trial enrolled a total of 65 metastatic breast cancer patients across 22 clinical sites in Europe and the United States. This patient population represents a significant unmet medical need, as these individuals have exhausted standard endocrine therapies and require alternative treatment options. The geographic distribution of clinical sites allows for a diverse patient sample, enhancing the generalizability of the trial results.
Eftilagimod Alpha (Efti) and Mechanism of Action
Eftilagimod alpha (efti) is a Lymphocyte Activation Gene-3 (LAG-3) immunotherapy being developed by Immutep for cancer and autoimmune diseases. It is designed to stimulate the immune response to fight cancer. The completion of enrollment in the AIPAC-003 trial marks a significant step forward in the clinical development of efti for metastatic breast cancer.
Next Steps and Data Analysis
Immutep plans to provide further updates after data collection, cleaning, and analysis. The results of this trial will be critical in determining the potential of efti as a new treatment option for patients with metastatic breast cancer. Investors and the medical community are keenly awaiting these results, as they could significantly impact Immutep's future prospects in the competitive oncology field.
