Onco-Summaries: Daily Oncology Updates at a Glance

15/04/2026

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• FDA Grants Orphan Drug Status to Immutep’s Eftilagimod Alfa in Soft Tissue Sarcoma

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FDA Grants Orphan Drug Status to Immutep’s Eftilagimod Alfa in Soft Tissue Sarcoma (Ref)

Immutep’s lead candidate, eftilagimod alfa (efti), has received Orphan Drug Designation from the U.S. FDA for soft tissue sarcoma (STS), a rare cancer with high unmet need

• Supporting clinical data:

  
  

  • Based on results from the Phase II EFTISARC-NEO trial combining efti with radiotherapy and pembrolizumab (KEYTRUDA®) in the neoadjuvant setting in patients with resectable soft tissue sarcoma

  
  

  • In 38 evaluable patients, the trial met its primary endpoint with median tumor hyalinization/fibrosis of 51.5%, surpassing the target of 35% and historical ~15% with radiotherapy alone

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