Immutep (NASDAQ: IMMP) has announced that the FDA has granted orphan drug designation (ODD) for eftilagimod alfa (efti) for the treatment of soft tissue sarcoma (STS), a rare cancer with significant unmet medical need.
According to Immutep, the designation was supported by encouraging clinical data from the investigator-initiated Phase 2 EFTISARC-NEO trial, which evaluated efti in combination with radiotherapy and KEYTRUDA in the neoadjuvant setting in patients with resectable soft tissue sarcoma.
In a statement, Marc Voigt, CEO of Immutep, commented, “We are pleased that the FDA has recognized the potential of efti for patients with soft tissue sarcoma, a rare and difficult to treat cancer. As previously communicated, the company is currently undertaking a comprehensive review and analysis following the discontinuation of its Phase 3 TACTI-004 trial and the outcome will influence the decision regarding any potential future clinical trial with efti. The FDA’s designation, based on very encouraging data from the EFTISARC-NEO trial, provides us with a potential direct step forward into a late-stage study in the neoadjuvant setting for STS.”
