Immutep Receives Positive Feedback from FDA on Late-Stage Clinical Development of Eftilagimod Alpha in Non-Small Cell Lung Cancer

Posted: 23 May 2023

Immutep Limited, a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces it has received positive feedback from the US Food and Drug Administration (FDA), regarding the Company’s late-stage clinical development plans for its first-in-class soluble LAG-3 protein and MHC Class II agonist, eftilagimod alpha (“efti”), for the treatment of 1st line nonsmall cell lung cancer (NSCLC).

The FDA is supportive of a registrational trial to evaluate efti in combination with an anti-PD-1 therapy based on the encouraging data from the Phase II TACTI-002, Part A (N=114) in 1st line NSCLC patients, no matter their level of PD-L1 expression, presented in a late-breaking oral abstract presentation at the 37th Annual Society of Immunotherapy of Cancer (SITC) Meeting in November 2022.

Among the items discussed at the meeting were the toxicological package and general aspects of the trial design, including statistics and potential patient population with a focus on 1st line NSCLC patients with a Tumor Proportion Score (TPS) PD-L1 of >1% for which efti plus pembrolizumab has already received Fast Track designation. This trial will be named TACTI-004 (Two ACTive Immunotherapies).

Immutep CEO, Marc Voigt, commented: “In light of our compelling clinical data that efti has generated in combination with anti-PD-1 therapy, this meeting with the FDA is a critical step in our late-stage development process for 1st line non-small cell lung cancer. We are thankful for the positive feedback as we continue moving forward with our unique immuno-oncology approach for the many cancer patients impacted by this difficult disease.”

Immutep CSO, Dr. Frédéric Triebel, stated: “We are very pleased with our constructive dialogue with the FDA establishing a clear path forward for efti in front line non-small cell lung cancer. These interactions represent an important milestone within Immutep’s three main clinical programs targeting cancers that affect large patient populations, positioning efti to make a significant impact for the many patients in need of more effective, tolerable, and durable immunotherapy.”

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