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Immutep - Fast Track granted by US FDA for Efti in 1st line NSCLC


  • Fast Track designation has been granted by the US FDA for efti in combination with pembrolizumab in 1st line non-small cell lung cancer
  • Based on the encouraging Phase II clinical data for PD-L1 all-comers presented at ASCO 2022
  • Marks the second Fast Track designation issued by the FDA for eftilagimod alpha, offering the potential for expedited development and review

SYDNEY, AUSTRALIA – 4 October 2022 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease, today announced 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 1st 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. 

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