Immutep Limited (ASX: $IMM) announces safety and initial efficacy data

Immutep Limited (ASX: $IMM) has released safety and initial efficacy data from the first ever 90mg dosing of eftilagimod alpha (efti) in combination with weekly paclitaxel in patients from the safety lead-in of the AIPAC-003 Phase II/III trial. The data shows that 90mg efti in combination with paclitaxel is safe and well tolerated, with encouraging initial efficacy in six metastatic breast cancer patients who exhausted all endocrine therapy including CDK4/6 inhibitors, demonstrating a 50% overall response rate, including one complete response, and a 100% disease control rate.

Executive Commentary on Clinical Data and Trial Progress

The safety and initial efficacy data from the 90mg dosing of efti in combination with paclitaxel is a significant milestone for Immutep. These results demonstrate the potential of efti as a novel LAG-3 immunotherapy for the treatment of cancer, particularly in metastatic breast cancer patients who have exhausted other treatment options. We are encouraged by the initial efficacy reports and the absence of treatment-emergent serious adverse events. The ongoing randomized Phase II portion of the trial will provide further insights into the safety and efficacy of 90mg efti dosing compared to 30mg dosing, and we look forward to the updates from AIPAC-003 in CY2024.

Summary of Immutep's Clinical Data and Outlook

Immutep's announcement of the safety and initial efficacy data from the 90mg dosing of efti in combination with paclitaxel marks a significant advancement in the development of novel LAG-3 immunotherapy for cancer. The encouraging initial efficacy in metastatic breast cancer patients, along with the absence of treatment-emergent serious adverse events, highlights the potential of efti as a promising treatment option. The ongoing randomized Phase II portion of the trial will provide further insights into the safety and efficacy of 90mg efti dosing compared to 30mg dosing, and the determination of the optimal biological dose in AIPAC-003 is directly tied to the FDA's Project Optimus initiative. Immutep's dedication to leveraging its expertise in LAG-3 immunotherapy demonstrates its commitment to bringing innovative treatment options to patients and maximizing value for shareholders.