Benzinga | Apr 8, 2021 05:51AM EDT

Immutep Announced it Received Fast Track Designation From the FDA for Efti, a Soluble Lag-3 Protein, in First Line Recurrent/Metastatic Head & Neck Cancer

Immutep Limited (NASDAQ:IMMP) announces its lead product candidate eftilagimod alpha ("efti" or "IMP321"), a soluble LAG-3 protein, has received Fast Track designation in 1st line recurrent or metastatic HNSCC 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 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 the promising results from Part C of Immutep's Phase II TACTI-002 trial evaluating efti in combination with KEYTRUDA® (pembrolizumab) 2nd line PD-X naive HNSCC, and its plans for a trial in 1st line HNSCC (TACTI-003). Interim clinical data from TACTI-002 was presented at the Society for Immunotherapy of Cancer (SITC) in November 2020. The Overall Response Rate (ORR) reported at SITC was approximately 36% (approximately 44% in evaluable patients) for 28 patients receiving efti in combination with KEYTRUDA. On 16 March 2021, Immutep announced that it had entered into a second collaboration with MSD (Merck & Co. Inc., Kenilworth, NJ, USA) to evaluate efti in combination with KEYTRUDA in a new Phase IIb trial in 1st line HNSCC, TACTI-003. Planning for this trial is advancing well and the study is expected to start in mid-2021.