Express First-line treatment of lung cancer, LAG-3 therapy is FDA fast-track qualified

Today, Immutep announced that the U.
S.
FDA has granted its potential "first-in-class" soluble LAG-3 fusion protein eftilagimod alpha (efti, aka IMP321) fast-track qualification, in combination with anti-PD-1 antibody Keytruda, for first-line treatment of non-small cell lung cancer (NSCLC
).
Efti is an investigational therapy in clinical development that mobilizes the innate and adaptive immune systems to target solid tumors by activating antigen-presenting cells (APCs
).

Efti is Immutep's potential "first-in-class" antigen-presenting cell agonist
.
It takes advantage of the properties of LAG-3 that can bind to antigen-presenting cells such as dendritic cells, monocytes, macrophages, etc.
, leading to the expansion of antitumor cells, as well as presenting antigens to the adaptive immune system, stimulating the proliferation
of CD4-positive and CD8-positive T cells.

The results of the clinical trials presented at this year's ASCO Annual Meeting showed that in the Phase 2 clinical trial, efti was combined with Keytruda, and the first-line treatment of NSCLC patients reached an objective response rate (ORR) of 38.
6%, reaching the main endpoint
of the trial.
The median progression-free survival was 6.
9 months
.
It is worth mentioning that in PD-L1-negative patients, this combination therapy also reached 28.
1% of ORR
.
Based on positive clinical outcomes, the company plans to prioritize the clinical development of efti and Keytruda first-line therapy for NSCLC
.

"We are pleased to qualify for the fast track, which demonstrates the potential
of efti to help the body's immune system fight cancer and significantly enhance patients' response to standard immunotherapy.
" Efti also offers a chemotherapy-free treatment option
for NSCLC patients.
Mr.
Marc Voigt, CEO of Immutep, said
.

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