FDA Backs Immutep's Eftilagimod Registrational Trial In Metastatic Breast Cancer

Immutep Limited IMMP has received constructive feedback from the FDA regarding its clinical development program for eftilagimod alpha (efti or IMP321) in metastatic breast cancer (MBC). 

• The agency has supported Immutep's view to continue exploring the development of efti in MBC in a new registrational trial. 
• The FDA's feedback was based on clinical data presented by Immutep, including final overall survival data from its Phase 2b AIPAC trial. 
• Final overall survival (OS) data showed that patients in the efti group had a median OS of 20.4 months compared to 17.5 months for patients in the comparator group.
• The advice from the FDA follows the receipt of feedback from the European Medicines Agency (EMA) regarding Immutep's clinical development program for efti, as announced in October 2021. 
• Related content: Benzinga's Full FDA Calendar. 
• Immutep CSO & CMO Frederic Triebel commented: "We are very pleased to have now received feedback from both the FDA and the EMA as part of our ongoing process to design a new registrational trial in MBC. As we have noted previously, many of these patients do not respond well to conventional immune checkpoint inhibitors and so it is important that we continue to advance efti, with its unique mechanism of action, with a carefully designed trial."
• Price Action: IMMP shares traded 0.70% higher at $2.89 during pre-market trading on Thursday.