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Immutep receives FDA Fast Track

Immutep, the biotechnology company developing novel immunotherapy treatments for cancer, infectious disease and autoimmune disease, announced its lead product candidate "efti”, has received Fast Track designation from the United States Food and Drug Administration (FDA).


Fast Track has been granted for the development program of efti for 1st line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) due to its potential to address an "unmet medical need", as evidenced by encouraging data indicating a positive risk-benefit ratio.


The data package evaluated by the FDA included promising results from Immutep’s Phase II trial evaluating efti in combination with KEYTRUDA, and its plans for the additional 1st line HNSCC trial. Interim clinical data from Phase II trial were presented at the Society for Immunotherapy of Cancer in November. The Overall Response Rate reported at SITC was approximately 36% for 28 patients receiving efti in combination with KEYTRUDA.


On 16 March 2021, Immutep announced that it had entered into a second collaboration with Merck & Co Inc, to evaluate efti in combination with KEYTRUDA in a new Phase IIb trial. The company reports planning for this trial is advancing well and the study is expected to start in mid-2021.


As a result of the fast-tracking, Immutep will now have access to more frequent meetings and communications with the FDA, potentially receive Rolling Review of its Biologic License Application and may be eligible for Accelerated Approval and Priority Review, if relevant criteria are met, for efti in HNSCC.


About Fast Track designation


FDA Fast Track designation is awarded to help important new therapies reach patients earlier. It is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need.