Media Release
- Confirmed complete response in a patient with metastatic breast cancer refractory to several lines of therapy achieved during combination treatment with 90mg efti and paclitaxel
- Ongoing complete response has been maintained since the patient started treatment with efti monotherapy
- Efti + paclitaxel combination continues to be well tolerated with a favourable safety profile
- First-ever 90mg dosing leads to higher maximum concentration of efti, as well as pharmacologically active level up to 96 hours after administration
- Data from randomized Phase II portion of study expected in CY2024
Efficacy
The poster titled “Testing a higher dose (90 mg s.c.) of eftilagimod alpha, a soluble LAG-3 protein, in metastatic breast cancer patients receiving weekly paclitaxel in
Complete Response Patient Case Study
The patient with a confirmed complete response (CR) was diagnosed with triple-negative breast carcinoma (TNBC) in 2019 and has failed multiple lines of therapy including a CDK 4/6 inhibitor for ER+/PR+ metastasis. During the immuno-oncology (IO)-chemotherapy treatment of efti and paclitaxel, this patient achieved a partial response (PR) that subsequently turned into a CR. This patient’s ongoing CR has been maintained since stopping paclitaxel and being treated with efti monotherapy.
Safety & Pharmacodynamic Effects
The lead-in has also shown that the first-ever 90mg efti dosing in combination with weekly paclitaxel continues to be well tolerated with a favourable safety profile. As of the data cut-off (
The 90mg efti dosing leads to a higher maximum concentration of efti in the blood as compared to lower efti doses in past clinical trials, and efti remains detectable at a pharmacologically active level (>1 ng/mL) up to 96 hours after administration. Pharmacodynamic effects also showed an increase of circulating levels of immune cells such as CD8 & CD4 T cells and plasma Th1 biomarker levels. All patients in the
Dr.
The randomized Phase II portion of the trial, which will include up to 58 evaluable patients, is underway and focused on whether 90mg efti dosing is more efficacious than 30mg dosing. This portion of the trial has enrolled 35 patients to date. Importantly, the determination of the optimal dose in
Further data updates in terms of safety and efficacy from
About Eftilagimod Alpha (Efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.
Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the
About
+61 (0)406 759 268; c.strong@morrowsodali.com
+1 (631) 318 4000; chris.basta@immutep.com
Source:
2024 GlobeNewswire, Inc., source