Immutep Limited says the United States Food and Drug Administration (FDA) has granted fast track designation to eftilagimod alpha (efti or IMP321) in combination with pembrolizumab for the treatment of first line non-small cell lung cancer (NSCLC).
Efti is the company’s first-in-class soluble LAG-3 clinical stage candidate, which activates antigen presenting cells (APC) to engage both the innate and adaptive immune system to target solid tumors.
“We are pleased to receive this fast track designation as it acknowledges efti’s unique potential to empower the human immune system against cancer and significantly enhance patient responses to standard-of-care immunotherapy. Efti also offers a chemotherapy-free option for NSCLC patients in need of less toxic and more durable solutions,” said Marc Voigt, CEO of Immutep.
“This important designation that efti has now received across two indications, 1st line NSCLC and first line HNSCC, enables us to work more closely with the FDA to bring this novel treatment option to cancer patients in the most timely and efficient manner possible. We look forward to providing additional clinical data in 1st line NSCLC later this year,” he added.
Based on trials
The FDA’s fast track designation process is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need. Immutep will now have access to more frequent interactions with the FDA to discuss efti’s development path and, if relevant criteria are met, eligibility for Rolling Review, Accelerated Approval, and Priority Review.
The designation has been granted for the development of efti in combination with pembrolizumab in first line treatment of stage IIIB/IV NSCLC patients expressing PD-L1 tumor proportion score greater than or equal to 1%, not amenable to EGFR/ALK based therapy. The designation is based on the TACTI-002/KEYNOTE-798 phase II clinical data in first line NSCLC for PD-L1 all-comers shared earlier this year at the American Society of Clinical Oncology’s (ASCO) 2022 annual meeting.
This represents the second fast track designation for efti, following the same designation in April 2021 for efti in combination with pembrolizumab in first line treatment of recurrent or metastatic head and neck squamous cell carcinoma.
About Immutep’s Eftilagimod Alpha
Efti is Immutep’s proprietary soluble LAG-3 clinical stage candidate that is a first-in-class antigen presenting cell (APC) activator for the treatment of cancer, in particular solid tumors. Efti capitalizes on LAG3’s unique characteristics to activate both innate and adaptive immunity via binding to antigen presenting cells such as dendritic cells, monocytes, and macrophages via MHC II molecules. Activation of APCs leads to expansion of anti-tumor cells, presentation of antigens to the adaptive immune system, and proliferation of CD4+ (helper) and CD8+ (cytotoxic) T cells. Efti’s favorable safety profile enables its use in various combination settings, including with anti-PD-[L]1 immunotherapy and/or chemotherapy.